sorbitol and Constriction, Pathologic

sorbitol has been researched along with Constriction, Pathologic in 1 studies

D-glucitol : The D-enantiomer of glucitol (also known as D-sorbitol).

Constriction, Pathologic: The condition of an anatomical structure's being constricted beyond normal dimensions.

Research

Studies (1)

Authors

Clinical Trials (6)

Trial Overview

Trial Outcomes

Angiographic Late Lumen Loss

Loss in analysis segment (the treated segment including 10mm distal and proximal) minimal lumen diameter from post-procedure through follow-up angiography at 6 months. (NCT00930813)
Timeframe: 6 months

Safety - Device Related Adverse Events

(NCT00930813)
Timeframe: 30 days

Major Adverse Events (MAEs) (Primary Safety Endpoint)

"RCT: MAE is defined as a composite of freedom from all-cause death through 1 month, target limb major amputation (defined as at or above the ankle) within 12 months, and/or Target Lesion Revascularization (TLR) within 12 months.~LB Substudy: Primary safety endpoint assesses the occurrence of MAE defined as all-cause death through 1 month, target limb major amputation and/or TLR at 6 and 12 months post-index procedure.~PK Substudy: Not analyzed for primary safety endpoint." (NCT03064126)
Timeframe: 12 months (6 months for LB substudy)

Number of Participants With Clinical Success Rate Assessment

Clinical success defined as procedural success without procedural complications including death, major target limb amputation, thrombosis of the target lesion, or clinically-driven TLR prior to discharge. (NCT03064126)
Timeframe: Day 0

Number of Participants With Primary Lesion Patency

"RCT outcome measure: Primary patency of the target lesion is determined by Peak Systolic Velocity Ratio (PSVR) ≤ 2.4 (by duplex ultrasound (DUS)) and freedom from clinically-driven Target Lesion Revascularization (TLR) within 12 months from procedure. Lesion patency is defined as freedom from more than 50% stenosis based on DUS PSVR comparing data within the treated segment to the proximal normal arterial segment. PSVR >2.4 suggests >50% stenosis.~LB Substudy outcome measure: Primary patency of the target lesion is determined by duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≤ 2.4 in absence of clinically-driven TLR. Primary effectiveness endpoint is assessed at 6 months post-procedure.~PK Substudy not analyzed for primary patency." (NCT03064126)
Timeframe: 12 months (6 months for LB substudy)

Number of Participants With Procedural Success of Angioplasty Procedure

Procedural success defined as residual stenosis of less than or equal to 50% (non-stented subjects) or less than or equal to 30% (stented subjects) by core laboratory evaluation. (NCT03064126)
Timeframe: Day 0

Number of Participants With Rate of Hemodynamic Improvement as Assessed by Changes in Ankle Brachial Index (ABI)

Improvement of ABI by ≥ 0.1 or to an ABI ≥ 0.90 as compared to the pre-procedure value without the need for repeat revascularization. (NCT03064126)
Timeframe: 12 months (6 months for LB substudy)

Number of Participants With Rate of Primary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline

Endpoint determined to be a success when there is an improvement in Rutherford Classification of one or more categories as compared to pre-procedure without the need for repeat TLR (NCT03064126)
Timeframe: 12 months (6 months for LB substudy)

Number of Participants With Rate of Secondary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification

Endpoint determined to be a success when there is an improvement in Rutherford Classification of one or more categories as compared to pre-procedure including those subjects with repeat TLR (NCT03064126)
Timeframe: 12 months (6 months for LB substudy)

Number of Participants With Technical Success of Angioplasty Procedure

Technical success defined as successful delivery, balloon inflation and deflation and retrieval of the intact trial device without burst below the rated burst pressure. (NCT03064126)
Timeframe: Day 0

Walking Improvement (Distance) Assessed by Change in Six Minute Walk Test (6MWT)

The 6MWT measure the maximal walking distance that a patient achieves on a flat, hard surface within a period of 6 minutes. It evaluates the global and integrated responses of all physiological systems involved during exercise including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, neuromuscular units and muscle metabolism. Change in distance walked from baseline to 12 months. (NCT03064126)
Timeframe: 12 months

Walking Improvement Assessed by Change in Walking Impairment Questionnaire (WIQ) From Baseline

The WIQ is a functional assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability. It also assesses the reasons that walking ability might be limited. Range of scores include 0% (worst score) to 100% (best score). Walking improvement change assessed from baseline to 12 months. (NCT03064126)
Timeframe: 12 months

Number of CEC Adjudicated Events Through 12 Months

Denominators for the cumulative rate will be based on 1) subjects with events, and 2) subjects with no events but their follow-up time reaches (or is beyond) the earliest visit window. (NCT03064126)
Timeframe: 12 months (6 Months for LB Substudy)

Number of Major Adverse Event (MAE) Assessment

MAEs defined as all-cause of death post-index procedure, target limb major amputation, and/or target lesion revascularization (TLR). (NCT03064126)
Timeframe: 12 months (6 months for LB substudy)

Trials

1 trial available for sorbitol and Constriction, Pathologic