Page last updated: 2024-10-17

lactic acid and Neointima

lactic acid has been researched along with Neointima in 16 studies

Lactic Acid: A normal intermediate in the fermentation (oxidation, metabolism) of sugar. The concentrated form is used internally to prevent gastrointestinal fermentation. (From Stedman, 26th ed)
2-hydroxypropanoic acid : A 2-hydroxy monocarboxylic acid that is propanoic acid in which one of the alpha-hydrogens is replaced by a hydroxy group.

Neointima: The new and thickened layer of scar tissue that forms on a PROSTHESIS, or as a result of vessel injury especially following ANGIOPLASTY or stent placement.

Research Excerpts

ExcerptRelevanceReference
" Propylthiouracil (PTU), an antithyroid drug, has been proven to suppress neointimal formation after balloon injury."7.88Propylthiouracil-coated biodegradable polymer inhibited neointimal formation and enhanced re-endothelialization after vascular injury. ( Chang, SH; Chen, WJ; Hsu, MY; Lee, CH; Liu, SJ; Wang, CJ; Yeh, YH, 2018)
" The DESolve system, designed to provide vessel support and neointimal suppression, combines a poly-l-lactic acid-based scaffold with the antiproliferative myolimus."5.19A next-generation bioresorbable coronary scaffold system: from bench to first clinical evaluation: 6- and 12-month clinical and multimodality imaging results. ( Abizaid, A; Abizaid, AS; Bhat, V; Chamie, D; Costa, JR; Costa, R; Morrison, L; Ormiston, JA; Pinto, I; Sanidas, E; Stewart, J; Toyloy, S; Verheye, S; Webster, M; Yan, J, 2014)
" Propylthiouracil (PTU), an antithyroid drug, has been proven to suppress neointimal formation after balloon injury."3.88Propylthiouracil-coated biodegradable polymer inhibited neointimal formation and enhanced re-endothelialization after vascular injury. ( Chang, SH; Chen, WJ; Hsu, MY; Lee, CH; Liu, SJ; Wang, CJ; Yeh, YH, 2018)
"PTCA-NC followed by local infusion of sirolimus nanoparticles was safe and efficacious to reduce neointima in this model, and this strategy may be a promising treatment for BMS ISR."3.79Local delivery of sirolimus nanoparticles for the treatment of in-stent restenosis. ( Attizzani, G; Balvedi, JA; Centeno, PR; Kosachenco, BG; Matte, BS; Nascimento, L; Raudales, JC; Yamamoto, GI; Zago, AC; Zago, AJ, 2013)
"0."1.38Enhanced drug delivery capabilities from stents coated with absorbable polymer and crystalline drug. ( Bailey, L; Carlyle, WC; Edelman, ER; Markham, PM; McClain, JB; Stanley, JR; Tzafriri, AR; Zani, BG, 2012)

Research

Studies (16)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's15 (93.75)24.3611
2020's1 (6.25)2.80

Authors

AuthorsStudies
Sasaki, N1
Ishii, A1
Yagi, S1
Nishi, H1
Akiyama, R1
Okawa, M1
Abekura, Y1
Tsuji, H1
Sakurai, S1
Miyamoto, S1
Chang, SH1
Lee, CH1
Yeh, YH1
Liu, SJ1
Wang, CJ1
Hsu, MY1
Chen, WJ1
Veeram Reddy, SR1
Welch, TR1
Wang, J1
Bernstein, F1
Richardson, JA1
Forbess, JM1
Nugent, AW1
Xu, H1
Kona, S1
Su, LC1
Tsai, YT1
Dong, JF1
Brilakis, ES1
Tang, L1
Banerjee, S1
Nguyen, KT1
Verheye, S1
Ormiston, JA1
Stewart, J1
Webster, M1
Sanidas, E1
Costa, R1
Costa, JR1
Chamie, D1
Abizaid, AS1
Pinto, I1
Morrison, L1
Toyloy, S1
Bhat, V1
Yan, J1
Abizaid, A1
Zhang, H1
Deng, W1
Wang, X1
Wang, S1
Ge, J1
Toft, E1
Watanabe, Y1
Miyagawa, S1
Fukushima, S1
Daimon, T1
Shirakawa, Y1
Kuratani, T1
Sawa, Y1
Tara, S1
Kurobe, H1
Rocco, KA1
Maxfield, MW1
Best, CA1
Yi, T1
Naito, Y1
Breuer, CK1
Shinoka, T1
Popova, IV1
Stepanova, AO1
Plotnikova, TA1
Sergeevichev, DS1
Akulov, AE1
Pokushalov, AA1
Laktionov, PP1
Karpenko, AA1
Wu, B1
Mottola, G1
Chatterjee, A1
Lance, KD1
Chen, M1
Siguenza, IO1
Desai, TA1
Conte, MS1
Izuhara, M1
Kuwabara, Y1
Saito, N1
Yamamoto, E1
Hakuno, D1
Nakashima, Y1
Horie, T1
Baba, O1
Nishiga, M1
Nakao, T1
Nishino, T1
Nakazeki, F1
Ide, Y1
Kimura, M1
Kimura, T1
Ono, K1
Liu, K1
Cao, G1
Zhang, X1
Liu, R1
Zou, W1
Wu, S1
Gutiérrez-Chico, JL1
Gijsen, F1
Regar, E1
Wentzel, J1
de Bruyne, B1
Thuesen, L1
Ormiston, J1
McClean, DR1
Windecker, S1
Chevalier, B1
Dudek, D1
Whitbourn, R1
Brugaletta, S1
Onuma, Y1
Serruys, PW1
Koppara, T1
Joner, M1
Bayer, G1
Steigerwald, K1
Diener, T1
Wittchow, E1
Zago, AC1
Raudales, JC1
Attizzani, G1
Matte, BS1
Yamamoto, GI1
Balvedi, JA1
Nascimento, L1
Kosachenco, BG1
Centeno, PR1
Zago, AJ1
Carlyle, WC1
McClain, JB1
Tzafriri, AR1
Bailey, L1
Zani, BG1
Markham, PM1
Stanley, JR1
Edelman, ER1

Clinical Trials (4)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Percutaneous Coronary Intervention With the ANgiolite Drug-Eluting Stent: an Optical CoHerence TOmogRaphy Study. The ANCHOR Study[NCT02776267]100 participants (Anticipated)Interventional2015-05-31Completed
A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System (BVS EECSS) in the Treatment of Patients With de Novo Native Coronary Artery Lesions.[NCT00856856]101 participants (Actual)Interventional2009-03-31Completed
Percutaneous Complete Revascularization Strategies Using Sirolimus Eluting Biodegradable Polymer Coated Stents in Patients Presenting With Acute Coronary Syndrome and Multivessel Disease[NCT03621501]1,525 participants (Actual)Interventional2018-06-22Active, not recruiting
Vessel Injury in Relation With Strut Thickness Assessed by OCT (VISTA): A Comparison of Vascular Injury Induced by a Polymer Free Sirolimus and Probucol Eluting Stent and a Biodegradable-polymer Biolimus-eluting Stent[NCT03026465]Phase 450 participants (Actual)Interventional2017-02-16Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

% of Acutely Covered Struts

(NCT00856856)
Timeframe: 2 years

InterventionPercent of Covered Struts (Mean)
Absorb BVS98.07

% of Acutely Covered Struts

(NCT00856856)
Timeframe: 3 years

InterventionPercent of Covered Struts (Mean)
Absorb BVS97.90

% of Covered Struts (150 µm)

(NCT00856856)
Timeframe: 1 year

InterventionPercent of Covered Struts (Mean)
Absorb BVS96.86

% of Uncovered Struts (150 µm)

(NCT00856856)
Timeframe: 1 year

InterventionPercent of Uncovered Struts (Mean)
Absorb BVS3.14

% of Uncovered Struts (150 µm)

(NCT00856856)
Timeframe: 2 years

InterventionPercent of Uncovered Struts (Mean)
Absorb BVS1.93

% of Uncovered Struts (150 µm)

(NCT00856856)
Timeframe: 3 years

InterventionPercent of Uncovered Struts (Mean)
Absorb BVS2.10

Aneurysm

An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times. (NCT00856856)
Timeframe: 1 year

InterventionPercentage of participants (Number)
Absorb BVS0.0

Aneurysm

An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times. (NCT00856856)
Timeframe: 180 days

InterventionPercentage of participants (Number)
Absorb BVS2.4

Aneurysm

An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times. (NCT00856856)
Timeframe: 2 years

InterventionPercentage of participants (Number)
Absorb BVS2.6

Aneurysm

An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times. (NCT00856856)
Timeframe: 3 years

InterventionPercentage of participants (Number)
Absorb BVS2.08

Aneurysm

An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times. (NCT00856856)
Timeframe: 5 years

InterventionPercentage of participants (Number)
Absorb BVS0.0

Cardiac Death

"Cardiac death is defined as any death in which a cardiac cause cannot be excluded.~(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)" (NCT00856856)
Timeframe: 1 year

Interventionpercentage of participants (Number)
ABSORB Stent0

Cardiac Death

"Cardiac death is defined as any death in which a cardiac cause cannot be excluded.~(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)" (NCT00856856)
Timeframe: 2 years

Interventionpercentage of participants (Number)
ABSORB Stent0

Cardiac Death

"Cardiac death is defined as any death in which a cardiac cause cannot be excluded.~(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)" (NCT00856856)
Timeframe: 3 years

Interventionpercentage of participants (Number)
ABSORB Stent0

Cardiac Death

"Cardiac death is defined as any death in which a cardiac cause cannot be excluded.~(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)" (NCT00856856)
Timeframe: 30 days

Interventionpercentage of participants (Number)
ABSORB Stent0

Cardiac Death

"Cardiac death is defined as any death in which a cardiac cause cannot be excluded.~(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)" (NCT00856856)
Timeframe: 4 years

Interventionpercentage of participants (Number)
ABSORB Stent0

Cardiac Death

"Cardiac death is defined as any death in which a cardiac cause cannot be excluded.~(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)" (NCT00856856)
Timeframe: 5 years

Interventionpercentage of participants (Number)
ABSORB Stent0

Clinical Device Success (Per Lesion)

Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout patients will be included as device success only if the above criteria for clinical device are met. (NCT00856856)
Timeframe: On day 0 (the day of procedure)

Interventionpercentage of lesions (Number)
Absorb BVS100.0

Clinical Procedure Success (Per Patient)

Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia-driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure. (NCT00856856)
Timeframe: On day 0 (the day of procedure)

Interventionpercentage of participants (Number)
ABSORB Stent98.0

Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 1 Year

Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement). (NCT00856856)
Timeframe: 1 year

InterventionMillimeter (Mean)
Absorb BVS0.07

Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 180 Days

Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement). (NCT00856856)
Timeframe: 180 days

InterventionMillimeter (Mean)
Absorb BVS0.07

Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 2 Years

Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement). (NCT00856856)
Timeframe: 2 years

InterventionMillimeter (Mean)
Absorb BVS0.04

Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 3 Years

Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement). (NCT00856856)
Timeframe: 3 years

InterventionMillimeter (Mean)
Absorb BVS0.08

Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 5 Years

Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement). (NCT00856856)
Timeframe: 5 years

InterventionMillimeter (Mean)
Absorb BVS0.11

Hierarchical Major Adverse Cardiac Event (MACE)

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR). (NCT00856856)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Absorb BVS6.9

Hierarchical Major Adverse Cardiac Event (MACE)

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR). (NCT00856856)
Timeframe: 180 days

Interventionpercentage of participants (Number)
Absorb BVS5.0

Hierarchical Major Adverse Cardiac Event (MACE)

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR). (NCT00856856)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Absorb BVS9.0

Hierarchical Major Adverse Cardiac Event (MACE)

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR). (NCT00856856)
Timeframe: 270 days

Interventionpercentage of participants (Number)
Absorb BVS5.0

Hierarchical Major Adverse Cardiac Event (MACE)

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR). (NCT00856856)
Timeframe: 3 years

Interventionpercentage of participants (Number)
Absorb BVS10.0

Hierarchical Major Adverse Cardiac Event (MACE)

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR). (NCT00856856)
Timeframe: 30 days

Interventionpercentage of participants (Number)
Absorb BVS2.0

Hierarchical Major Adverse Cardiac Event (MACE)

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR). (NCT00856856)
Timeframe: 4 years

Interventionpercentage of participants (Number)
Absorb BVS10.1

Hierarchical Major Adverse Cardiac Event (MACE)

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR). (NCT00856856)
Timeframe: 5 years

Interventionpercentage of participants (Number)
Absorb BVS11.0

Hierarchical Target Vessel Failure (TVF)

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). (NCT00856856)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Absorb BVS6.9

Hierarchical Target Vessel Failure (TVF)

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). (NCT00856856)
Timeframe: 180 days

InterventionPercentage of participants (Number)
ABSORB Stent5.0

Hierarchical Target Vessel Failure (TVF)

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). (NCT00856856)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Absorb BVS11.0

Hierarchical Target Vessel Failure (TVF)

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). (NCT00856856)
Timeframe: 270 days

InterventionPercentage of participants (Number)
Absorb Stent5.0

Hierarchical Target Vessel Failure (TVF)

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). (NCT00856856)
Timeframe: 3 years

Interventionpercentage of participants (Number)
Absorb BVS13.0

Hierarchical Target Vessel Failure (TVF)

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). (NCT00856856)
Timeframe: 30 days

Interventionpercentage of participants (Number)
Absorb BVS2.0

Hierarchical Target Vessel Failure (TVF)

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). (NCT00856856)
Timeframe: 4 years

Interventionpercentage of participants (Number)
Absorb BVS13.1

Hierarchical Target Vessel Failure (TVF)

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). (NCT00856856)
Timeframe: 5 years

Interventionpercentage of participants (Number)
Absorb BVS14.0

In-scaffold Angiographic Binary Restenosis (ABR)

Percent of patients with a followup percent diameter stenosis of >=50% per QCA. (NCT00856856)
Timeframe: 1 year

InterventionPercentage of participants (Number)
Absorb BVS3.5

In-scaffold Angiographic Binary Restenosis (ABR)

Percent of patients with a followup percent diameter stenosis of >=50% per QCA. (NCT00856856)
Timeframe: 180 days

InterventionPercentage of participants (Number)
Absorb BVS0.0

In-scaffold Angiographic Binary Restenosis (ABR)

Percent of patients with a followup percent diameter stenosis of >=50% per QCA. (NCT00856856)
Timeframe: 2 years

InterventionPercentage of participants (Number)
Absorb BVS0.0

In-scaffold Angiographic Binary Restenosis (ABR)

Percent of patients with a followup percent diameter stenosis of >=50% per QCA. (NCT00856856)
Timeframe: 3 years

InterventionPercentage of participants (Number)
Absorb BVS7.8

In-scaffold Angiographic Binary Restenosis (ABR)

Percent of patients with a followup percent diameter stenosis of >=50% per QCA. (NCT00856856)
Timeframe: 5 years

InterventionPercentage of participants (Number)
Absorb BVS7.8

In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 2 Years

In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up. (NCT00856856)
Timeframe: 2 years

InterventionMillimeter (Mean)
Absorb BVS0.27

In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 3 Years

In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up. (NCT00856856)
Timeframe: 3 years

InterventionMillimeter (Mean)
Absorb BVS0.29

In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 5 Years

In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up. (NCT00856856)
Timeframe: 5 years

InterventionMillimeter (Mean)
Absorb BVS0.26

In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 1 Year

In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up (NCT00856856)
Timeframe: 1 year

InterventionMillimeter (Mean)
Absorb BVS0.27

In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 180 Days

In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up. (NCT00856856)
Timeframe: 180 days

InterventionMillimeter (Mean)
Absorb BVS0.19

In-scaffold Percent Diameter Stenosis (%DS)

Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA. (NCT00856856)
Timeframe: 1 year

Interventionpercentage of diameter stenosis (Mean)
Absorb BVS21.35

In-scaffold Percent Diameter Stenosis (%DS)

Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA. (NCT00856856)
Timeframe: 180 days

Interventionpercentage of diameter stenosis (Mean)
Absorb BVS19.21

In-scaffold Percent Diameter Stenosis (%DS)

Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA. (NCT00856856)
Timeframe: 2 years

Interventionpercentage of diameter stenosis (Mean)
Absorb BVS20.94

In-scaffold Percent Diameter Stenosis (%DS)

Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA. (NCT00856856)
Timeframe: 3 years

Interventionpercentage of diameter stenosis (Mean)
Absorb BVS23.16

In-scaffold Percent Diameter Stenosis (%DS)

Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA. (NCT00856856)
Timeframe: 5 years

Interventionpercentage of diameter stenosis (Mean)
Absorb BVS22.74

Ischemia Driven Target Lesion Revascularization (ID-TLR)

"ID-TLR is defined as the revascularization at the target lesion associated with any of the following:~Positive functional ischemia study~Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study." (NCT00856856)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Absorb BVS4.0

Ischemia Driven Target Lesion Revascularization (ID-TLR)

"ID-TLR is defined as the revascularization at the target lesion associated with any of the following:~Positive functional ischemia study~Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study." (NCT00856856)
Timeframe: 180 days

InterventionPercentage of participants (Number)
Absorb BVS2.0

Ischemia Driven Target Lesion Revascularization (ID-TLR)

"ID-TLR is defined as the revascularization at the target lesion associated with any of the following:~Positive functional ischemia study~Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study." (NCT00856856)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Absorb BVS6.0

Ischemia Driven Target Lesion Revascularization (ID-TLR)

"ID-TLR is defined as the revascularization at the target lesion associated with any of the following:~Positive functional ischemia study~Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study." (NCT00856856)
Timeframe: 270 days

InterventionPercentage of participants (Number)
Absorb BVS2.0

Ischemia Driven Target Lesion Revascularization (ID-TLR)

"ID-TLR is defined as the revascularization at the target lesion associated with any of the following:~Positive functional ischemia study~Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study." (NCT00856856)
Timeframe: 3 years

Interventionpercentage of participants (Number)
Absorb BVS7.0

Ischemia Driven Target Lesion Revascularization (ID-TLR)

"ID-TLR is defined as the revascularization at the target lesion associated with any of the following:~Positive functional ischemia study~Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study." (NCT00856856)
Timeframe: 30 days

Interventionpercentage of participants (Number)
Absorb BVS0

Ischemia Driven Target Lesion Revascularization (ID-TLR)

"ID-TLR is defined as the revascularization at the target lesion associated with any of the following:~Positive functional ischemia study~Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study." (NCT00856856)
Timeframe: 4 years

Interventionpercentage of participants (Number)
Absorb BVS7.1

Ischemia Driven Target Lesion Revascularization (ID-TLR)

"ID-TLR is defined as the revascularization at the target lesion associated with any of the following:~Positive functional ischemia study~Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study." (NCT00856856)
Timeframe: 5 years

Interventionpercentage of participants (Number)
Absorb BVS8.0

Ischemia Driven Target Vessel Revascularization (ID-TVR)

"ID-TVR is the revascularization in the target vessel associated with any of the following:~Positive functional ischemia study~Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study." (NCT00856856)
Timeframe: 1 year

InterventionPercentage of participants (Number)
Absorb BVS4.0

Ischemia Driven Target Vessel Revascularization (ID-TVR)

"ID-TVR is the revascularization in the target vessel associated with any of the following:~Positive functional ischemia study~Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study." (NCT00856856)
Timeframe: 180 days

InterventionPercentage of participants (Number)
Absorb BVS2.0

Ischemia Driven Target Vessel Revascularization (ID-TVR)

"ID-TVR is the revascularization in the target vessel associated with any of the following:~Positive functional ischemia study~Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study." (NCT00856856)
Timeframe: 2 years

InterventionPercentage of participants (Number)
Absorb BVS8.0

Ischemia Driven Target Vessel Revascularization (ID-TVR)

"ID-TVR is the revascularization in the target vessel associated with any of the following:~Positive functional ischemia study~Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study." (NCT00856856)
Timeframe: 270 days

InterventionPercentage of participants (Number)
Absorb BVS2.0

Ischemia Driven Target Vessel Revascularization (ID-TVR)

"ID-TVR is the revascularization in the target vessel associated with any of the following:~Positive functional ischemia study~Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study." (NCT00856856)
Timeframe: 3 years

InterventionPercentage of participants (Number)
Absorb BVS10.0

Ischemia Driven Target Vessel Revascularization (ID-TVR)

"ID-TVR is the revascularization in the target vessel associated with any of the following:~Positive functional ischemia study~Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study." (NCT00856856)
Timeframe: 30 days

InterventionPercentage of participants (Number)
Absorb BVS0.0

Ischemia Driven Target Vessel Revascularization (ID-TVR)

"ID-TVR is the revascularization in the target vessel associated with any of the following:~Positive functional ischemia study~Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study." (NCT00856856)
Timeframe: 4 years

InterventionPercentage of participants (Number)
Absorb BVS10.0

Ischemia Driven Target Vessel Revascularization (ID-TVR)

"ID-TVR is the revascularization in the target vessel associated with any of the following:~Positive functional ischemia study~Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study." (NCT00856856)
Timeframe: 5 years

InterventionPercentage of participants (Number)
Absorb BVS11.0

Late Incomplete Apposition

"Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure.~Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image." (NCT00856856)
Timeframe: 1 year

InterventionPercentage of participants (Number)
Absorb BVS3.6

Late Incomplete Apposition

"Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure.~Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image." (NCT00856856)
Timeframe: 180 days

InterventionPercentage of participants (Number)
Absorb BVS7.5

Late Incomplete Apposition

"Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure.~Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image." (NCT00856856)
Timeframe: 2 year

InterventionPercentage of participants (Number)
Absorb BVS2.6

Late Incomplete Apposition

"Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure.~Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image." (NCT00856856)
Timeframe: 3 year

InterventionPercentage of participants (Number)
Absorb BVS7.0

Luminal Volume

(NCT00856856)
Timeframe: 1 year

Interventionmm^3 (Mean)
Absorb BVS106.33

Luminal Volume

(NCT00856856)
Timeframe: 2 years

Interventionmm^3 (Mean)
Absorb BVS107.66

Luminal Volume

(NCT00856856)
Timeframe: 3 years

Interventionmm^3 (Mean)
Absorb BVS103.31

Luminal Volume

(NCT00856856)
Timeframe: 5 years

Interventionmm^3 (Mean)
Absorb BVS106.36

Mean Flow Area

(NCT00856856)
Timeframe: 1 year

Interventionmm^2 (Mean)
Absorb BVS5.90

Mean Flow Area

(NCT00856856)
Timeframe: 2 years

Interventionmm^2 (Mean)
Absorb BVS6.00

Mean Flow Area

(NCT00856856)
Timeframe: 3 years

Interventionmm^2 (Mean)
Absorb BVS6.06

Mean Flow Area

(NCT00856856)
Timeframe: 5 years

Interventionmm^2 (Mean)
Absorb BVS6.21

Mean Luminal Area

(NCT00856856)
Timeframe: 1 year

Interventionmm^2 (Mean)
Absorb BVS5.92

Mean Luminal Area

(NCT00856856)
Timeframe: 2 years

Interventionmm^2 (Mean)
Absorb BVS6.00

Mean Luminal Area

(NCT00856856)
Timeframe: 3 years

Interventionmm^2 (Mean)
Absorb BVS6.06

Mean Luminal Area

(NCT00856856)
Timeframe: 5 years

Interventionmm^2 (Mean)
Absorb BVS6.22

Mean Luminal Diameter

(NCT00856856)
Timeframe: 1 year

Interventionmm (Mean)
Absorb BVS2.71

Mean Luminal Diameter

(NCT00856856)
Timeframe: 2 years

Interventionmm (Mean)
Absorb BVS2.72

Mean Luminal Diameter

(NCT00856856)
Timeframe: 3 years

Interventionmm (Mean)
Absorb BVS2.74

Mean Luminal Diameter

It is measured during QCA by the Angiographic Core Lab. (NCT00856856)
Timeframe: 5 years

Interventionmm (Mean)
Absorb BVS2.77

Mean Reference Area

(NCT00856856)
Timeframe: 1 year

Interventionmm^2 (Mean)
Absorb BVS6.34

Mean Reference Area

(NCT00856856)
Timeframe: 2 years

Interventionmm^2 (Mean)
Absorb BVS6.29

Mean Reference Area

(NCT00856856)
Timeframe: 3 years

Interventionmm^2 (Mean)
Absorb BVS6.24

Mean Reference Area

(NCT00856856)
Timeframe: 5 years

Interventionmm^2 (Mean)
Absorb BVS6.13

Mean Scaffold Area

(NCT00856856)
Timeframe: 2 years

Interventionmm^2 (Mean)
Absorb BVS8.14

Mean Scaffold Area

(NCT00856856)
Timeframe: 3 years

Interventionmm^2 (Mean)
Absorb BVS8.50

Mean Scaffold Diameter

(NCT00856856)
Timeframe: 2 years

Interventionmm (Mean)
Absorb BVS3.19

Mean Scaffold Diameter

(NCT00856856)
Timeframe: 3 years

Interventionmm (Mean)
Absorb BVS3.26

Mean Stent Area

(NCT00856856)
Timeframe: 1 year

Interventionmm^2 (Mean)
Absorb BVS7.42

Mean Stent Diameter

(NCT00856856)
Timeframe: 1 year

Interventionmm (Mean)
Absorb BVS3.06

Mean Strut Core Area

(NCT00856856)
Timeframe: 1 year

Interventionmm^2 (Mean)
Absorb BVS0.17

Mean Strut Core Area

(NCT00856856)
Timeframe: 2 years

Interventionmm^2 (Mean)
Absorb BVS0.15

Mean Strut Core Area

(NCT00856856)
Timeframe: 3 years

Interventionmm^2 (Mean)
Absorb BVS0.19

Minimum Flow Area

(NCT00856856)
Timeframe: 1 year

Interventionmm^2 (Mean)
Absorb BVS4.28

Minimum Flow Area

(NCT00856856)
Timeframe: 2 years

Interventionmm^2 (Mean)
Absorb BVS4.29

Minimum Flow Area

(NCT00856856)
Timeframe: 3 years

Interventionmm^2 (Mean)
Absorb BVS4.45

Minimum Flow Area

(NCT00856856)
Timeframe: 5 years

Interventionmm^2 (Mean)
Absorb BVS4.15

Minimum Luminal Area

(NCT00856856)
Timeframe: 1 year

Interventionmm^2 (Mean)
Absorb BVS4.29

Minimum Luminal Area

(NCT00856856)
Timeframe: 2 years

Interventionmm^2 (Mean)
Absorb BVS4.29

Minimum Luminal Area

(NCT00856856)
Timeframe: 3 years

Interventionmm^2 (Mean)
Absorb BVS4.45

Minimum Luminal Area

(NCT00856856)
Timeframe: 5 years

Interventionmm^2 (Mean)
Absorb BVS4.15

Minimum Luminal Diameter

The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab. (NCT00856856)
Timeframe: 2 years

Interventionmm (Mean)
Absorb BVS2.30

Minimum Luminal Diameter

The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab. (NCT00856856)
Timeframe: 3 years

Interventionmm (Mean)
Absorb BVS2.34

Minimum Luminal Diameter

The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab. (NCT00856856)
Timeframe: 5 years

Interventionmm (Mean)
Absorb BVS2.25

Minimum Luminal Diameter (MLD)

The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab. (NCT00856856)
Timeframe: 1 year

Interventionmm (Mean)
Absorb BVS2.30

Minimum Scaffold Area

(NCT00856856)
Timeframe: 2 year

Interventionmm^2 (Mean)
Absorb BVS6.33

Minimum Scaffold Area

(NCT00856856)
Timeframe: 3 years

Interventionmm^2 (Mean)
Absorb BVS6.66

Minimum Scaffold Diameter

(NCT00856856)
Timeframe: 2 years

Interventionmm (Mean)
Absorb BVS2.82

Minimum Scaffold Diameter

(NCT00856856)
Timeframe: 3 years

Interventionmm (Mean)
Absorb BVS2.89

Minimum Stent Area

(NCT00856856)
Timeframe: 1 year

Interventionmm^2 (Mean)
Absorb BVS5.96

Minimum Stent Diameter

(NCT00856856)
Timeframe: 1 year

Interventionmm (Mean)
Absorb BVS2.74

Myocardial Infarction

"Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves." (NCT00856856)
Timeframe: 1 year

Interventionpercentage of participants (Number)
ABSORB Stent3.0

Myocardial Infarction

"Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves." (NCT00856856)
Timeframe: 2 years

Interventionpercentage of participants (Number)
ABSORB Stent3.0

Myocardial Infarction

"Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves." (NCT00856856)
Timeframe: 3 years

Interventionpercentage of participants (Number)
ABSORB Stent3.0

Myocardial Infarction

"Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves." (NCT00856856)
Timeframe: 4 years

Interventionpercentage of participants (Number)
ABSORB Stent3.0

Myocardial Infarction

"Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves." (NCT00856856)
Timeframe: 5 years

Interventionpercentage of participants (Number)
ABSORB Stent3.0

Myocardial Infarction

"Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves." (NCT00856856)
Timeframe: 30 days

Interventionpercentage of participants (Number)
ABSORB Stent2.0

Number of Struts in Side Branch

(NCT00856856)
Timeframe: 1 year

InterventionNumber of struts (Mean)
Absorb BVS0.1

Number of Struts in Side Branch

(NCT00856856)
Timeframe: 2 years

InterventionNumber of struts (Mean)
Absorb BVS0.2

Number of Struts in Side Branch

(NCT00856856)
Timeframe: 3 years

InterventionNumber of struts (Mean)
Absorb BVS0.2

Number of Struts in Side Branch

(NCT00856856)
Timeframe: 5 years

InterventionNumber of struts (Mean)
Absorb BVS0.0

Number of Struts Per BVS

(NCT00856856)
Timeframe: 1 year

InterventionNumber of Struts (Mean)
Absorb BVS162.1

Number of Struts Per BVS

(NCT00856856)
Timeframe: 2 years

InterventionNumber of Struts (Mean)
Absorb BVS160.9

Number of Struts Per BVS

(NCT00856856)
Timeframe: 3 years

InterventionNumber of Struts (Mean)
Absorb BVS145.2

Number of Struts Per BVS

(NCT00856856)
Timeframe: 5 years

InterventionNumber of Struts (Mean)
Absorb BVS7.1

Percent (%) Lumen Area Stenosis

(NCT00856856)
Timeframe: 1 year

InterventionPercentage of Lumen Area Stenosis (Mean)
Absorb BVS28.70

Percent (%) Lumen Area Stenosis

(NCT00856856)
Timeframe: 2 years

InterventionPercentage of Lumen Area Stenosis (Mean)
Absorb BVS28.75

Percent (%) Lumen Area Stenosis

(NCT00856856)
Timeframe: 3 years

InterventionPercentage of Lumen Area Stenosis (Mean)
Absorb BVS28.01

Percent (%) Lumen Area Stenosis

(NCT00856856)
Timeframe: 5 years

InterventionPercentage of Lumen Area Stenosis (Mean)
Absorb BVS34.32

Persisting Dissection

Dissection at follow-up that was present post-procedure. (NCT00856856)
Timeframe: 1 year

InterventionPercentage of participants (Number)
Absorb BVS0.0

Persisting Dissection

Dissection at follow-up that was present post-procedure. (NCT00856856)
Timeframe: 180 days

InterventionPercentage of participants (Number)
Absorb BVS0.0

Persisting Dissection

Dissection at follow-up that was present post-procedure. (NCT00856856)
Timeframe: 2 years

InterventionPercentage of participants (Number)
Absorb BVS0.0

Persisting Dissection

Dissection at follow-up that was present post-procedure. (NCT00856856)
Timeframe: 3 years

InterventionPercentage of participants (Number)
Absorb BVS0.0

Persisting Dissection

Dissection at follow-up that was present post-procedure. (NCT00856856)
Timeframe: 5 years

InterventionPercentage of participants (Number)
Absorb BVS0.0

Persisting Incomplete Apposition

"Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.~Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image." (NCT00856856)
Timeframe: 1 year

InterventionPercentage of participants (Number)
Absorb BVS3.5

Persisting Incomplete Apposition

"Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.~Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image." (NCT00856856)
Timeframe: 180 days

InterventionPercentage of participants (Number)
Absorb BVS2.3

Persisting Incomplete Apposition

"Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.~Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image." (NCT00856856)
Timeframe: 2 year

InterventionPercentage of participants (Number)
Absorb BVS0.0

Persisting Incomplete Apposition

"Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.~Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image." (NCT00856856)
Timeframe: 3 year

InterventionPercentage of participants (Number)
Absorb BVS0.0

Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 1 Year

Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement). (NCT00856856)
Timeframe: 1 year

InterventionMillimeter (Mean)
Absorb BVS0.12

Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 180 Days

Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement). (NCT00856856)
Timeframe: 180 days

InterventionMillimeter (Mean)
Absorb BVS0.07

Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 2 Years

Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement). (NCT00856856)
Timeframe: 2 years

InterventionMillimeter (Mean)
Absorb BVS0.12

Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 3 Years

Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement). (NCT00856856)
Timeframe: 3 years

InterventionMillimeter (Mean)
Absorb BVS0.14

Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 5 Years

Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement). (NCT00856856)
Timeframe: 5 years

InterventionMillimeter (Mean)
Absorb BVS0.14

Scaffold Thrombosis

"Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)~In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)~Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis." (NCT00856856)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Absorb BVS0

Scaffold Thrombosis

"Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)~In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)~Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis." (NCT00856856)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Absorb BVS0

Scaffold Thrombosis

"Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)~In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)~Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis." (NCT00856856)
Timeframe: 3 years

Interventionpercentage of participants (Number)
Absorb BVS0

Scaffold Thrombosis

"Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)~In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)~Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis." (NCT00856856)
Timeframe: 30 days

Interventionpercentage of participants (Number)
ABSORB Stent0

Scaffold Thrombosis

"Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)~In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)~Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis." (NCT00856856)
Timeframe: 4 years

Interventionpercentage of participants (Number)
Absorb BVS0

Scaffold Thrombosis

"Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)~In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)~Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis." (NCT00856856)
Timeframe: 5 years

Interventionpercentage of participants (Number)
Absorb BVS0

Scaffold Volume

(NCT00856856)
Timeframe: 2 years

Interventionmm^3 (Mean)
Absorb BVS145.78

Scaffold Volume

(NCT00856856)
Timeframe: 3 years

Interventionmm^3 (Mean)
Absorb BVS145.07

Stent Volume

(NCT00856856)
Timeframe: 1 year

Interventionmm^3 (Mean)
Absorb BVS132.90

Strut Volume

(NCT00856856)
Timeframe: 1 year

Interventionmm^3 (Mean)
Absorb BVS3.02

Strut Volume

(NCT00856856)
Timeframe: 2 years

Interventionmm^3 (Mean)
Absorb BVS2.61

Strut Volume

(NCT00856856)
Timeframe: 3 years

Interventionmm^3 (Mean)
Absorb BVS3.28

Thrombus

(NCT00856856)
Timeframe: 1 year

InterventionPercentage of participants (Number)
Absorb BVS0.0

Thrombus

(NCT00856856)
Timeframe: 180 days

InterventionPercentage of participants (Number)
Absorb BVS0.0

Thrombus

(NCT00856856)
Timeframe: 2 years

InterventionPercentage of participants (Number)
Absorb BVS2.6

Thrombus

(NCT00856856)
Timeframe: 3 years

InterventionPercentage of participants (Number)
Absorb BVS2.08

Thrombus

(NCT00856856)
Timeframe: 5 years

InterventionPercentage of participants (Number)
Absorb BVS0.0

Tissue Coverage Area BVS (Neointimal Area)

(NCT00856856)
Timeframe: 1 year

Interventionmm^2 (Mean)
Absorb BVS1.38

Tissue Coverage Area BVS (Neointimal Area)

(NCT00856856)
Timeframe: 2 years

Interventionmm^2 (Mean)
Absorb BVS1.99

Tissue Coverage Area BVS (Neointimal Area)

(NCT00856856)
Timeframe: 3 years

Interventionmm^2 (Mean)
Absorb BVS2.25

Tissue Coverage Area Classical

(NCT00856856)
Timeframe: 1 year

Interventionmm^2 (Mean)
Absorb BVS1.54

Tissue Coverage Area Classical

(NCT00856856)
Timeframe: 2 years

Interventionmm^2 (Mean)
Absorb BVS2.13

Tissue Coverage Area Classical

(NCT00856856)
Timeframe: 3 years

Interventionmm^2 (Mean)
Absorb BVS2.44

Tissue Coverage Obstruction Volume BVS

(NCT00856856)
Timeframe: 1 year

InterventionPercent of Tissue Coverage Obstruction (Mean)
Absorb BVS19.40

Tissue Coverage Obstruction Volume BVS

(NCT00856856)
Timeframe: 2 years

InterventionPercent of Tissue Coverage Obstruction (Mean)
Absorb BVS25.22

Tissue Coverage Obstruction Volume BVS

(NCT00856856)
Timeframe: 3 years

InterventionPercent of Tissue Coverage Obstruction (Mean)
Absorb BVS27.01

Tissue Coverage Obstruction Volume Classical

(NCT00856856)
Timeframe: 1 year

InterventionPercent of Tissue Coverage Obstruction (Mean)
Absorb BVS21.61

Tissue Coverage Obstruction Volume Classical

(NCT00856856)
Timeframe: 2 years

InterventionPercent of Tissue Coverage Obstruction (Mean)
Absorb BVS27.10

Tissue Coverage Obstruction Volume Classical

(NCT00856856)
Timeframe: 3 years

InterventionPercent of Tissue Coverage Obstruction (Mean)
Absorb BVS29.36

Tissue Coverage Volume BVS

(NCT00856856)
Timeframe: 1 year

Interventionmm^3 (Mean)
Absorb BVS24.40

Tissue Coverage Volume BVS

(NCT00856856)
Timeframe: 2 years

Interventionmm^3 (Mean)
Absorb BVS35.51

Tissue Coverage Volume BVS

(NCT00856856)
Timeframe: 3 years

Interventionmm^3 (Mean)
Absorb BVS38.47

Tissue Coverage Volume Classical

(NCT00856856)
Timeframe: 1 year

Interventionmm^3 (Mean)
Absorb BVS27.27

Tissue Coverage Volume Classical

(NCT00856856)
Timeframe: 2 years

Interventionmm^3 (Mean)
Absorb BVS38.12

Tissue Coverage Volume Classical

(NCT00856856)
Timeframe: 3 years

Interventionmm^3 (Mean)
Absorb BVS41.76

Volume Obstruction (VO)

Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS. (NCT00856856)
Timeframe: 1 year

Interventionpercent of scaffold volume (Mean)
Absorb BVS1.47

Volume Obstruction (VO)

Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS. (NCT00856856)
Timeframe: 180 days

Interventionpercent of scaffold volume (Mean)
Absorb BVS1.22

Volume Obstruction (VO)

Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS. (NCT00856856)
Timeframe: 2 year

Interventionpercent of scaffold volume (Mean)
Absorb BVS3.33

Volume Obstruction (VO)

Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS. (NCT00856856)
Timeframe: 3 year

Interventionpercent of scaffold volume (Mean)
Absorb BVS4.19

Vasomotion Analysis: In-scaffold Mean Luminal Diameter

Vasomotion function was assessed in reaction to nitrate administration. (NCT00856856)
Timeframe: 5 years

InterventionMillimeter (Mean)
Pre-NitroPost-Nitro
Absorb BVS2.492.56

Trials

1 trial available for lactic acid and Neointima

ArticleYear
A next-generation bioresorbable coronary scaffold system: from bench to first clinical evaluation: 6- and 12-month clinical and multimodality imaging results.
    JACC. Cardiovascular interventions, 2014, Volume: 7, Issue:1

    Topics: Absorbable Implants; Aged; Aged, 80 and over; Belgium; Cardiovascular Agents; Coronary Angiography;

2014

Other Studies

15 other studies available for lactic acid and Neointima

ArticleYear
Bioresorbable Poly (L-Lactic Acid) Flow Diverter Versus Cobalt-Chromium Flow Diverter: In Vitro and In Vivo Analysis.
    Stroke, 2023, Volume: 54, Issue:6

    Topics: Absorbable Implants; Animals; Chromium; Cobalt; Endovascular Procedures; Intracranial Aneurysm; Lact

2023
Propylthiouracil-coated biodegradable polymer inhibited neointimal formation and enhanced re-endothelialization after vascular injury.
    International journal of nanomedicine, 2018, Volume: 13

    Topics: Absorbable Implants; Animals; Aorta; Cell Movement; Cell Proliferation; Drug-Eluting Stents; Endothe

2018
A novel biodegradable stent applicable for use in congenital heart disease: bench testing and feasibility results in a rabbit model.
    Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 2014, Feb-15, Volume: 83, Issue:3

    Topics: Absorbable Implants; Animals; Arterial Occlusive Diseases; Arteritis; Cardiac Catheterization; Cathe

2014
Multi-ligand poly(L-lactic-co-glycolic acid) nanoparticles inhibit activation of endothelial cells.
    Journal of cardiovascular translational research, 2013, Volume: 6, Issue:4

    Topics: Animals; Anti-Inflammatory Agents; Carotid Artery Injuries; Carotid Artery, Common; Carotid Stenosis

2013
Solely abluminal drug release from coronary stents could possibly improve reendothelialization.
    Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 2016, Volume: 88, Issue:3

    Topics: Animals; Cardiovascular Agents; Cell Proliferation; Coronary Angiography; Coronary Vessels; Drug-Elu

2016
Development of a prostacyclin-agonist-eluting aortic stent graft enhancing biological attachment to the aortic wall.
    The Journal of thoracic and cardiovascular surgery, 2014, Volume: 148, Issue:5

    Topics: Adhesiveness; Animals; Aorta, Thoracic; Biomarkers; Blood Vessel Prosthesis; Blood Vessel Prosthesis

2014
Well-organized neointima of large-pore poly(L-lactic acid) vascular graft coated with poly(L-lactic-co-ε-caprolactone) prevents calcific deposition compared to small-pore electrospun poly(L-lactic acid) graft in a mouse aortic implantation model.
    Atherosclerosis, 2014, Volume: 237, Issue:2

    Topics: Animals; Arteries; Calcinosis; Collagen; Elastin; Female; Inflammation; Lactic Acid; Macrophages; Mi

2014
[Study of patency of vascular grafts manufactured by means of electrospinning].
    Angiologiia i sosudistaia khirurgiia = Angiology and vascular surgery, 2015, Volume: 21, Issue:2

    Topics: Animals; Aorta, Abdominal; Biocompatible Materials; Blood Vessel Prosthesis; Glycolates; Graft Occlu

2015
Perivascular delivery of resolvin D1 inhibits neointimal hyperplasia in a rat model of arterial injury.
    Journal of vascular surgery, 2017, Volume: 65, Issue:1

    Topics: Angioplasty, Balloon; Animals; Aorta; Cardiovascular Agents; Carotid Artery Diseases; Cell Movement;

2017
Prevention of neointimal formation using miRNA-126-containing nanoparticle-conjugated stents in a rabbit model.
    PloS one, 2017, Volume: 12, Issue:3

    Topics: Animals; Base Sequence; Cell Movement; Cell Proliferation; Cholesterol; Drug Carriers; Drug-Eluting

2017
Pretreatment with intraluminal rapamycin nanoparticle perfusion inhibits neointimal hyperplasia in a rabbit vein graft model.
    International journal of nanomedicine, 2010, Oct-21, Volume: 5

    Topics: Animals; Graft Occlusion, Vascular; In Vitro Techniques; Jugular Veins; Lactic Acid; Models, Animal;

2010
Differences in neointimal thickness between the adluminal and the abluminal sides of malapposed and side-branch struts in a polylactide bioresorbable scaffold: evidence in vivo about the abluminal healing process.
    JACC. Cardiovascular interventions, 2012, Volume: 5, Issue:4

    Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Australia; Cardiovascular Agents; Cell Pr

2012
Histopathological comparison of biodegradable polymer and permanent polymer based sirolimus eluting stents in a porcine model of coronary stent implantation.
    Thrombosis and haemostasis, 2012, Volume: 107, Issue:6

    Topics: Absorbable Implants; Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Coronary Angiog

2012
Histopathological comparison of biodegradable polymer and permanent polymer based sirolimus eluting stents in a porcine model of coronary stent implantation.
    Thrombosis and haemostasis, 2012, Volume: 107, Issue:6

    Topics: Absorbable Implants; Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Coronary Angiog

2012
Histopathological comparison of biodegradable polymer and permanent polymer based sirolimus eluting stents in a porcine model of coronary stent implantation.
    Thrombosis and haemostasis, 2012, Volume: 107, Issue:6

    Topics: Absorbable Implants; Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Coronary Angiog

2012
Histopathological comparison of biodegradable polymer and permanent polymer based sirolimus eluting stents in a porcine model of coronary stent implantation.
    Thrombosis and haemostasis, 2012, Volume: 107, Issue:6

    Topics: Absorbable Implants; Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Coronary Angiog

2012
Local delivery of sirolimus nanoparticles for the treatment of in-stent restenosis.
    Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 2013, Volume: 81, Issue:2

    Topics: Acrylic Resins; Animals; Cardiac Catheters; Cardiovascular Agents; Chemistry, Pharmaceutical; Corona

2013
Enhanced drug delivery capabilities from stents coated with absorbable polymer and crystalline drug.
    Journal of controlled release : official journal of the Controlled Release Society, 2012, Sep-28, Volume: 162, Issue:3

    Topics: Animals; Anti-Inflammatory Agents; Constriction, Pathologic; Coronary Vessels; Crystallization; Drug

2012