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.
Excerpt | Relevance | Reference |
---|---|---|
" Propylthiouracil (PTU), an antithyroid drug, has been proven to suppress neointimal formation after balloon injury." | 7.88 | Propylthiouracil-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." | 5.19 | A 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." | 3.88 | Propylthiouracil-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." | 3.79 | Local 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." | 1.38 | Enhanced 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) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 0 (0.00) | 29.6817 |
2010's | 15 (93.75) | 24.3611 |
2020's | 1 (6.25) | 2.80 |
Authors | Studies |
---|---|
Sasaki, N | 1 |
Ishii, A | 1 |
Yagi, S | 1 |
Nishi, H | 1 |
Akiyama, R | 1 |
Okawa, M | 1 |
Abekura, Y | 1 |
Tsuji, H | 1 |
Sakurai, S | 1 |
Miyamoto, S | 1 |
Chang, SH | 1 |
Lee, CH | 1 |
Yeh, YH | 1 |
Liu, SJ | 1 |
Wang, CJ | 1 |
Hsu, MY | 1 |
Chen, WJ | 1 |
Veeram Reddy, SR | 1 |
Welch, TR | 1 |
Wang, J | 1 |
Bernstein, F | 1 |
Richardson, JA | 1 |
Forbess, JM | 1 |
Nugent, AW | 1 |
Xu, H | 1 |
Kona, S | 1 |
Su, LC | 1 |
Tsai, YT | 1 |
Dong, JF | 1 |
Brilakis, ES | 1 |
Tang, L | 1 |
Banerjee, S | 1 |
Nguyen, KT | 1 |
Verheye, S | 1 |
Ormiston, JA | 1 |
Stewart, J | 1 |
Webster, M | 1 |
Sanidas, E | 1 |
Costa, R | 1 |
Costa, JR | 1 |
Chamie, D | 1 |
Abizaid, AS | 1 |
Pinto, I | 1 |
Morrison, L | 1 |
Toyloy, S | 1 |
Bhat, V | 1 |
Yan, J | 1 |
Abizaid, A | 1 |
Zhang, H | 1 |
Deng, W | 1 |
Wang, X | 1 |
Wang, S | 1 |
Ge, J | 1 |
Toft, E | 1 |
Watanabe, Y | 1 |
Miyagawa, S | 1 |
Fukushima, S | 1 |
Daimon, T | 1 |
Shirakawa, Y | 1 |
Kuratani, T | 1 |
Sawa, Y | 1 |
Tara, S | 1 |
Kurobe, H | 1 |
Rocco, KA | 1 |
Maxfield, MW | 1 |
Best, CA | 1 |
Yi, T | 1 |
Naito, Y | 1 |
Breuer, CK | 1 |
Shinoka, T | 1 |
Popova, IV | 1 |
Stepanova, AO | 1 |
Plotnikova, TA | 1 |
Sergeevichev, DS | 1 |
Akulov, AE | 1 |
Pokushalov, AA | 1 |
Laktionov, PP | 1 |
Karpenko, AA | 1 |
Wu, B | 1 |
Mottola, G | 1 |
Chatterjee, A | 1 |
Lance, KD | 1 |
Chen, M | 1 |
Siguenza, IO | 1 |
Desai, TA | 1 |
Conte, MS | 1 |
Izuhara, M | 1 |
Kuwabara, Y | 1 |
Saito, N | 1 |
Yamamoto, E | 1 |
Hakuno, D | 1 |
Nakashima, Y | 1 |
Horie, T | 1 |
Baba, O | 1 |
Nishiga, M | 1 |
Nakao, T | 1 |
Nishino, T | 1 |
Nakazeki, F | 1 |
Ide, Y | 1 |
Kimura, M | 1 |
Kimura, T | 1 |
Ono, K | 1 |
Liu, K | 1 |
Cao, G | 1 |
Zhang, X | 1 |
Liu, R | 1 |
Zou, W | 1 |
Wu, S | 1 |
Gutiérrez-Chico, JL | 1 |
Gijsen, F | 1 |
Regar, E | 1 |
Wentzel, J | 1 |
de Bruyne, B | 1 |
Thuesen, L | 1 |
Ormiston, J | 1 |
McClean, DR | 1 |
Windecker, S | 1 |
Chevalier, B | 1 |
Dudek, D | 1 |
Whitbourn, R | 1 |
Brugaletta, S | 1 |
Onuma, Y | 1 |
Serruys, PW | 1 |
Koppara, T | 1 |
Joner, M | 1 |
Bayer, G | 1 |
Steigerwald, K | 1 |
Diener, T | 1 |
Wittchow, E | 1 |
Zago, AC | 1 |
Raudales, JC | 1 |
Attizzani, G | 1 |
Matte, BS | 1 |
Yamamoto, GI | 1 |
Balvedi, JA | 1 |
Nascimento, L | 1 |
Kosachenco, BG | 1 |
Centeno, PR | 1 |
Zago, AJ | 1 |
Carlyle, WC | 1 |
McClain, JB | 1 |
Tzafriri, AR | 1 |
Bailey, L | 1 |
Zani, BG | 1 |
Markham, PM | 1 |
Stanley, JR | 1 |
Edelman, ER | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
Percutaneous Coronary Intervention With the ANgiolite Drug-Eluting Stent: an Optical CoHerence TOmogRaphy Study. The ANCHOR Study[NCT02776267] | 100 participants (Anticipated) | Interventional | 2015-05-31 | Completed | |||
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) | Interventional | 2009-03-31 | Completed | |||
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) | Interventional | 2018-06-22 | Active, 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 4 | 50 participants (Actual) | Interventional | 2017-02-16 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
(NCT00856856)
Timeframe: 2 years
Intervention | Percent of Covered Struts (Mean) |
---|---|
Absorb BVS | 98.07 |
(NCT00856856)
Timeframe: 3 years
Intervention | Percent of Covered Struts (Mean) |
---|---|
Absorb BVS | 97.90 |
(NCT00856856)
Timeframe: 1 year
Intervention | Percent of Covered Struts (Mean) |
---|---|
Absorb BVS | 96.86 |
(NCT00856856)
Timeframe: 1 year
Intervention | Percent of Uncovered Struts (Mean) |
---|---|
Absorb BVS | 3.14 |
(NCT00856856)
Timeframe: 2 years
Intervention | Percent of Uncovered Struts (Mean) |
---|---|
Absorb BVS | 1.93 |
(NCT00856856)
Timeframe: 3 years
Intervention | Percent of Uncovered Struts (Mean) |
---|---|
Absorb BVS | 2.10 |
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
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 0.0 |
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
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 2.4 |
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
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 2.6 |
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
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 2.08 |
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
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 0.0 |
"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
Intervention | percentage of participants (Number) |
---|---|
ABSORB Stent | 0 |
"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
Intervention | percentage of participants (Number) |
---|---|
ABSORB Stent | 0 |
"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
Intervention | percentage of participants (Number) |
---|---|
ABSORB Stent | 0 |
"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
Intervention | percentage of participants (Number) |
---|---|
ABSORB Stent | 0 |
"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
Intervention | percentage of participants (Number) |
---|---|
ABSORB Stent | 0 |
"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
Intervention | percentage of participants (Number) |
---|---|
ABSORB Stent | 0 |
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)
Intervention | percentage of lesions (Number) |
---|---|
Absorb BVS | 100.0 |
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)
Intervention | percentage of participants (Number) |
---|---|
ABSORB Stent | 98.0 |
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
Intervention | Millimeter (Mean) |
---|---|
Absorb BVS | 0.07 |
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
Intervention | Millimeter (Mean) |
---|---|
Absorb BVS | 0.07 |
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
Intervention | Millimeter (Mean) |
---|---|
Absorb BVS | 0.04 |
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
Intervention | Millimeter (Mean) |
---|---|
Absorb BVS | 0.08 |
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
Intervention | Millimeter (Mean) |
---|---|
Absorb BVS | 0.11 |
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
Intervention | percentage of participants (Number) |
---|---|
Absorb BVS | 6.9 |
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
Intervention | percentage of participants (Number) |
---|---|
Absorb BVS | 5.0 |
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
Intervention | percentage of participants (Number) |
---|---|
Absorb BVS | 9.0 |
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
Intervention | percentage of participants (Number) |
---|---|
Absorb BVS | 5.0 |
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
Intervention | percentage of participants (Number) |
---|---|
Absorb BVS | 10.0 |
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
Intervention | percentage of participants (Number) |
---|---|
Absorb BVS | 2.0 |
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
Intervention | percentage of participants (Number) |
---|---|
Absorb BVS | 10.1 |
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
Intervention | percentage of participants (Number) |
---|---|
Absorb BVS | 11.0 |
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
Intervention | percentage of participants (Number) |
---|---|
Absorb BVS | 6.9 |
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
Intervention | Percentage of participants (Number) |
---|---|
ABSORB Stent | 5.0 |
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
Intervention | percentage of participants (Number) |
---|---|
Absorb BVS | 11.0 |
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
Intervention | Percentage of participants (Number) |
---|---|
Absorb Stent | 5.0 |
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
Intervention | percentage of participants (Number) |
---|---|
Absorb BVS | 13.0 |
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
Intervention | percentage of participants (Number) |
---|---|
Absorb BVS | 2.0 |
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
Intervention | percentage of participants (Number) |
---|---|
Absorb BVS | 13.1 |
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
Intervention | percentage of participants (Number) |
---|---|
Absorb BVS | 14.0 |
Percent of patients with a followup percent diameter stenosis of >=50% per QCA. (NCT00856856)
Timeframe: 1 year
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 3.5 |
Percent of patients with a followup percent diameter stenosis of >=50% per QCA. (NCT00856856)
Timeframe: 180 days
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 0.0 |
Percent of patients with a followup percent diameter stenosis of >=50% per QCA. (NCT00856856)
Timeframe: 2 years
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 0.0 |
Percent of patients with a followup percent diameter stenosis of >=50% per QCA. (NCT00856856)
Timeframe: 3 years
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 7.8 |
Percent of patients with a followup percent diameter stenosis of >=50% per QCA. (NCT00856856)
Timeframe: 5 years
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 7.8 |
In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up. (NCT00856856)
Timeframe: 2 years
Intervention | Millimeter (Mean) |
---|---|
Absorb BVS | 0.27 |
In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up. (NCT00856856)
Timeframe: 3 years
Intervention | Millimeter (Mean) |
---|---|
Absorb BVS | 0.29 |
In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up. (NCT00856856)
Timeframe: 5 years
Intervention | Millimeter (Mean) |
---|---|
Absorb BVS | 0.26 |
In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up (NCT00856856)
Timeframe: 1 year
Intervention | Millimeter (Mean) |
---|---|
Absorb BVS | 0.27 |
In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up. (NCT00856856)
Timeframe: 180 days
Intervention | Millimeter (Mean) |
---|---|
Absorb BVS | 0.19 |
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
Intervention | percentage of diameter stenosis (Mean) |
---|---|
Absorb BVS | 21.35 |
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
Intervention | percentage of diameter stenosis (Mean) |
---|---|
Absorb BVS | 19.21 |
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
Intervention | percentage of diameter stenosis (Mean) |
---|---|
Absorb BVS | 20.94 |
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
Intervention | percentage of diameter stenosis (Mean) |
---|---|
Absorb BVS | 23.16 |
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
Intervention | percentage of diameter stenosis (Mean) |
---|---|
Absorb BVS | 22.74 |
"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
Intervention | percentage of participants (Number) |
---|---|
Absorb BVS | 4.0 |
"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
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 2.0 |
"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
Intervention | percentage of participants (Number) |
---|---|
Absorb BVS | 6.0 |
"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
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 2.0 |
"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
Intervention | percentage of participants (Number) |
---|---|
Absorb BVS | 7.0 |
"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
Intervention | percentage of participants (Number) |
---|---|
Absorb BVS | 0 |
"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
Intervention | percentage of participants (Number) |
---|---|
Absorb BVS | 7.1 |
"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
Intervention | percentage of participants (Number) |
---|---|
Absorb BVS | 8.0 |
"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
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 4.0 |
"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
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 2.0 |
"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
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 8.0 |
"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
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 2.0 |
"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
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 10.0 |
"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
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 0.0 |
"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
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 10.0 |
"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
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 11.0 |
"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
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 3.6 |
"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
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 7.5 |
"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
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 2.6 |
"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
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 7.0 |
(NCT00856856)
Timeframe: 1 year
Intervention | mm^3 (Mean) |
---|---|
Absorb BVS | 106.33 |
(NCT00856856)
Timeframe: 2 years
Intervention | mm^3 (Mean) |
---|---|
Absorb BVS | 107.66 |
(NCT00856856)
Timeframe: 3 years
Intervention | mm^3 (Mean) |
---|---|
Absorb BVS | 103.31 |
(NCT00856856)
Timeframe: 5 years
Intervention | mm^3 (Mean) |
---|---|
Absorb BVS | 106.36 |
(NCT00856856)
Timeframe: 1 year
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 5.90 |
(NCT00856856)
Timeframe: 2 years
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 6.00 |
(NCT00856856)
Timeframe: 3 years
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 6.06 |
(NCT00856856)
Timeframe: 5 years
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 6.21 |
(NCT00856856)
Timeframe: 1 year
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 5.92 |
(NCT00856856)
Timeframe: 2 years
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 6.00 |
(NCT00856856)
Timeframe: 3 years
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 6.06 |
(NCT00856856)
Timeframe: 5 years
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 6.22 |
(NCT00856856)
Timeframe: 1 year
Intervention | mm (Mean) |
---|---|
Absorb BVS | 2.71 |
(NCT00856856)
Timeframe: 2 years
Intervention | mm (Mean) |
---|---|
Absorb BVS | 2.72 |
(NCT00856856)
Timeframe: 3 years
Intervention | mm (Mean) |
---|---|
Absorb BVS | 2.74 |
It is measured during QCA by the Angiographic Core Lab. (NCT00856856)
Timeframe: 5 years
Intervention | mm (Mean) |
---|---|
Absorb BVS | 2.77 |
(NCT00856856)
Timeframe: 1 year
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 6.34 |
(NCT00856856)
Timeframe: 2 years
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 6.29 |
(NCT00856856)
Timeframe: 3 years
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 6.24 |
(NCT00856856)
Timeframe: 5 years
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 6.13 |
(NCT00856856)
Timeframe: 2 years
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 8.14 |
(NCT00856856)
Timeframe: 3 years
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 8.50 |
(NCT00856856)
Timeframe: 2 years
Intervention | mm (Mean) |
---|---|
Absorb BVS | 3.19 |
(NCT00856856)
Timeframe: 3 years
Intervention | mm (Mean) |
---|---|
Absorb BVS | 3.26 |
(NCT00856856)
Timeframe: 1 year
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 7.42 |
(NCT00856856)
Timeframe: 1 year
Intervention | mm (Mean) |
---|---|
Absorb BVS | 3.06 |
(NCT00856856)
Timeframe: 1 year
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 0.17 |
(NCT00856856)
Timeframe: 2 years
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 0.15 |
(NCT00856856)
Timeframe: 3 years
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 0.19 |
(NCT00856856)
Timeframe: 1 year
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 4.28 |
(NCT00856856)
Timeframe: 2 years
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 4.29 |
(NCT00856856)
Timeframe: 3 years
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 4.45 |
(NCT00856856)
Timeframe: 5 years
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 4.15 |
(NCT00856856)
Timeframe: 1 year
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 4.29 |
(NCT00856856)
Timeframe: 2 years
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 4.29 |
(NCT00856856)
Timeframe: 3 years
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 4.45 |
(NCT00856856)
Timeframe: 5 years
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 4.15 |
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
Intervention | mm (Mean) |
---|---|
Absorb BVS | 2.30 |
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
Intervention | mm (Mean) |
---|---|
Absorb BVS | 2.34 |
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
Intervention | mm (Mean) |
---|---|
Absorb BVS | 2.25 |
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
Intervention | mm (Mean) |
---|---|
Absorb BVS | 2.30 |
(NCT00856856)
Timeframe: 2 year
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 6.33 |
(NCT00856856)
Timeframe: 3 years
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 6.66 |
(NCT00856856)
Timeframe: 2 years
Intervention | mm (Mean) |
---|---|
Absorb BVS | 2.82 |
(NCT00856856)
Timeframe: 3 years
Intervention | mm (Mean) |
---|---|
Absorb BVS | 2.89 |
(NCT00856856)
Timeframe: 1 year
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 5.96 |
(NCT00856856)
Timeframe: 1 year
Intervention | mm (Mean) |
---|---|
Absorb BVS | 2.74 |
"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
Intervention | percentage of participants (Number) |
---|---|
ABSORB Stent | 3.0 |
"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
Intervention | percentage of participants (Number) |
---|---|
ABSORB Stent | 3.0 |
"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
Intervention | percentage of participants (Number) |
---|---|
ABSORB Stent | 3.0 |
"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
Intervention | percentage of participants (Number) |
---|---|
ABSORB Stent | 3.0 |
"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
Intervention | percentage of participants (Number) |
---|---|
ABSORB Stent | 3.0 |
"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
Intervention | percentage of participants (Number) |
---|---|
ABSORB Stent | 2.0 |
(NCT00856856)
Timeframe: 1 year
Intervention | Number of struts (Mean) |
---|---|
Absorb BVS | 0.1 |
(NCT00856856)
Timeframe: 2 years
Intervention | Number of struts (Mean) |
---|---|
Absorb BVS | 0.2 |
(NCT00856856)
Timeframe: 3 years
Intervention | Number of struts (Mean) |
---|---|
Absorb BVS | 0.2 |
(NCT00856856)
Timeframe: 5 years
Intervention | Number of struts (Mean) |
---|---|
Absorb BVS | 0.0 |
(NCT00856856)
Timeframe: 1 year
Intervention | Number of Struts (Mean) |
---|---|
Absorb BVS | 162.1 |
(NCT00856856)
Timeframe: 2 years
Intervention | Number of Struts (Mean) |
---|---|
Absorb BVS | 160.9 |
(NCT00856856)
Timeframe: 3 years
Intervention | Number of Struts (Mean) |
---|---|
Absorb BVS | 145.2 |
(NCT00856856)
Timeframe: 5 years
Intervention | Number of Struts (Mean) |
---|---|
Absorb BVS | 7.1 |
(NCT00856856)
Timeframe: 1 year
Intervention | Percentage of Lumen Area Stenosis (Mean) |
---|---|
Absorb BVS | 28.70 |
(NCT00856856)
Timeframe: 2 years
Intervention | Percentage of Lumen Area Stenosis (Mean) |
---|---|
Absorb BVS | 28.75 |
(NCT00856856)
Timeframe: 3 years
Intervention | Percentage of Lumen Area Stenosis (Mean) |
---|---|
Absorb BVS | 28.01 |
(NCT00856856)
Timeframe: 5 years
Intervention | Percentage of Lumen Area Stenosis (Mean) |
---|---|
Absorb BVS | 34.32 |
Dissection at follow-up that was present post-procedure. (NCT00856856)
Timeframe: 1 year
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 0.0 |
Dissection at follow-up that was present post-procedure. (NCT00856856)
Timeframe: 180 days
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 0.0 |
Dissection at follow-up that was present post-procedure. (NCT00856856)
Timeframe: 2 years
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 0.0 |
Dissection at follow-up that was present post-procedure. (NCT00856856)
Timeframe: 3 years
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 0.0 |
Dissection at follow-up that was present post-procedure. (NCT00856856)
Timeframe: 5 years
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 0.0 |
"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
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 3.5 |
"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
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 2.3 |
"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
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 0.0 |
"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
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 0.0 |
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
Intervention | Millimeter (Mean) |
---|---|
Absorb BVS | 0.12 |
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
Intervention | Millimeter (Mean) |
---|---|
Absorb BVS | 0.07 |
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
Intervention | Millimeter (Mean) |
---|---|
Absorb BVS | 0.12 |
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
Intervention | Millimeter (Mean) |
---|---|
Absorb BVS | 0.14 |
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
Intervention | Millimeter (Mean) |
---|---|
Absorb BVS | 0.14 |
"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
Intervention | percentage of participants (Number) |
---|---|
Absorb BVS | 0 |
"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
Intervention | percentage of participants (Number) |
---|---|
Absorb BVS | 0 |
"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
Intervention | percentage of participants (Number) |
---|---|
Absorb BVS | 0 |
"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
Intervention | percentage of participants (Number) |
---|---|
ABSORB Stent | 0 |
"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
Intervention | percentage of participants (Number) |
---|---|
Absorb BVS | 0 |
"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
Intervention | percentage of participants (Number) |
---|---|
Absorb BVS | 0 |
(NCT00856856)
Timeframe: 2 years
Intervention | mm^3 (Mean) |
---|---|
Absorb BVS | 145.78 |
(NCT00856856)
Timeframe: 3 years
Intervention | mm^3 (Mean) |
---|---|
Absorb BVS | 145.07 |
(NCT00856856)
Timeframe: 1 year
Intervention | mm^3 (Mean) |
---|---|
Absorb BVS | 132.90 |
(NCT00856856)
Timeframe: 1 year
Intervention | mm^3 (Mean) |
---|---|
Absorb BVS | 3.02 |
(NCT00856856)
Timeframe: 2 years
Intervention | mm^3 (Mean) |
---|---|
Absorb BVS | 2.61 |
(NCT00856856)
Timeframe: 3 years
Intervention | mm^3 (Mean) |
---|---|
Absorb BVS | 3.28 |
(NCT00856856)
Timeframe: 1 year
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 0.0 |
(NCT00856856)
Timeframe: 180 days
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 0.0 |
(NCT00856856)
Timeframe: 2 years
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 2.6 |
(NCT00856856)
Timeframe: 3 years
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 2.08 |
(NCT00856856)
Timeframe: 5 years
Intervention | Percentage of participants (Number) |
---|---|
Absorb BVS | 0.0 |
(NCT00856856)
Timeframe: 1 year
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 1.38 |
(NCT00856856)
Timeframe: 2 years
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 1.99 |
(NCT00856856)
Timeframe: 3 years
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 2.25 |
(NCT00856856)
Timeframe: 1 year
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 1.54 |
(NCT00856856)
Timeframe: 2 years
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 2.13 |
(NCT00856856)
Timeframe: 3 years
Intervention | mm^2 (Mean) |
---|---|
Absorb BVS | 2.44 |
(NCT00856856)
Timeframe: 1 year
Intervention | Percent of Tissue Coverage Obstruction (Mean) |
---|---|
Absorb BVS | 19.40 |
(NCT00856856)
Timeframe: 2 years
Intervention | Percent of Tissue Coverage Obstruction (Mean) |
---|---|
Absorb BVS | 25.22 |
(NCT00856856)
Timeframe: 3 years
Intervention | Percent of Tissue Coverage Obstruction (Mean) |
---|---|
Absorb BVS | 27.01 |
(NCT00856856)
Timeframe: 1 year
Intervention | Percent of Tissue Coverage Obstruction (Mean) |
---|---|
Absorb BVS | 21.61 |
(NCT00856856)
Timeframe: 2 years
Intervention | Percent of Tissue Coverage Obstruction (Mean) |
---|---|
Absorb BVS | 27.10 |
(NCT00856856)
Timeframe: 3 years
Intervention | Percent of Tissue Coverage Obstruction (Mean) |
---|---|
Absorb BVS | 29.36 |
(NCT00856856)
Timeframe: 1 year
Intervention | mm^3 (Mean) |
---|---|
Absorb BVS | 24.40 |
(NCT00856856)
Timeframe: 2 years
Intervention | mm^3 (Mean) |
---|---|
Absorb BVS | 35.51 |
(NCT00856856)
Timeframe: 3 years
Intervention | mm^3 (Mean) |
---|---|
Absorb BVS | 38.47 |
(NCT00856856)
Timeframe: 1 year
Intervention | mm^3 (Mean) |
---|---|
Absorb BVS | 27.27 |
(NCT00856856)
Timeframe: 2 years
Intervention | mm^3 (Mean) |
---|---|
Absorb BVS | 38.12 |
(NCT00856856)
Timeframe: 3 years
Intervention | mm^3 (Mean) |
---|---|
Absorb BVS | 41.76 |
Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS. (NCT00856856)
Timeframe: 1 year
Intervention | percent of scaffold volume (Mean) |
---|---|
Absorb BVS | 1.47 |
Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS. (NCT00856856)
Timeframe: 180 days
Intervention | percent of scaffold volume (Mean) |
---|---|
Absorb BVS | 1.22 |
Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS. (NCT00856856)
Timeframe: 2 year
Intervention | percent of scaffold volume (Mean) |
---|---|
Absorb BVS | 3.33 |
Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS. (NCT00856856)
Timeframe: 3 year
Intervention | percent of scaffold volume (Mean) |
---|---|
Absorb BVS | 4.19 |
Vasomotion function was assessed in reaction to nitrate administration. (NCT00856856)
Timeframe: 5 years
Intervention | Millimeter (Mean) | |
---|---|---|
Pre-Nitro | Post-Nitro | |
Absorb BVS | 2.49 | 2.56 |
1 trial available for lactic acid and Neointima
Article | Year |
---|---|
A next-generation bioresorbable coronary scaffold system: from bench to first clinical evaluation: 6- and 12-month clinical and multimodality imaging results.
Topics: Absorbable Implants; Aged; Aged, 80 and over; Belgium; Cardiovascular Agents; Coronary Angiography; | 2014 |
15 other studies available for lactic acid and Neointima
Article | Year |
---|---|
Bioresorbable Poly (L-Lactic Acid) Flow Diverter Versus Cobalt-Chromium Flow Diverter: In Vitro and In Vivo Analysis.
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.
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.
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.
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.
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.
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.
Topics: Animals; Arteries; Calcinosis; Collagen; Elastin; Female; Inflammation; Lactic Acid; Macrophages; Mi | 2014 |
[Study of patency of vascular grafts manufactured by means of electrospinning].
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.
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.
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.
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.
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.
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.
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.
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.
Topics: Absorbable Implants; Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Coronary Angiog | 2012 |
Local delivery of sirolimus nanoparticles for the treatment of in-stent restenosis.
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.
Topics: Animals; Anti-Inflammatory Agents; Constriction, Pathologic; Coronary Vessels; Crystallization; Drug | 2012 |