Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal (TRUTH)
|ClinicalTrials.gov Identifier: NCT01938391|
Recruitment Status : Completed
First Posted : September 10, 2013
Results First Posted : August 18, 2017
Last Update Posted : August 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Artery Disease PAD Claudication Peripheral Vascular Disease PVD||Device: Stealth 360°® OAS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal (TRUTH Study)|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
OAS + BA
Cardiovascular Systems, Inc. Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA)
Device: Stealth 360°® OAS
Cardiovascular Systems, Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)
- Rate of Clinically Driven Target Lesion Revascularization (TLR) [ Time Frame: 6 months and 12 months ]A Kaplan-Meier analysis was performed to determine the percent probability that a study participant had a TLR at 6 months and at 12 months.
- Mean Maximum Balloon Inflation Pressure [ Time Frame: Index Procedure ]Mean maximum balloon inflation pressure of balloons used pre-stent placement.
- Rate of Procedural Angiographic Complications [ Time Frame: Index Procedure ]Percent of study participants with an Investigator reported procedural angiographic complication (flow limiting dissection, perforation, slow flow/no flow, distal embolization and recoil).
- Ankle-Brachial Index (ABI) Measurments [ Time Frame: Baseline, 2 weeks, 6 months and 12 months ]The ankle-brachial index (ABI) is the ratio of the systolic blood pressure (SBP) measured at the ankle to that measured at the brachial (upper arm) artery. Normal range of ABI is 0.9 - 1.2. Values less than 0.9 suggests presence of peripheral artery disease (PAD). Values greater than 1.2 suggests of non-compressible vessel.
- Rutherford Classification (RC) [ Time Frame: Baseline, 2 weeks, 6 month and 12 month ]
Rutherford Classification (RC) is a commonly used clinical grading system for describing peripheral arterial disease (PAD) on a scale of 0 to 6. RC 6 is the most severe form of PAD. The RC is assessed for each participant at baseline and at each follow-up visit.
RC classification is as follows:
RC 0: Asymptomatic, no hemodynamically significant occlusive disease RC 1-3: Mild to Severe Claudication, limitation with ordinary physical activities, patient is comfortable at rest RC 4-5: Ischemic rest pain, minor tissue loss, non healing ulcer, focal gangrene RC 6: Major tissue loss, functional foot no longer salvageable
- Stent Usage at the Time of the Index Procedure [ Time Frame: Index Procedure ]Number of lesions with a stent placed during the index procedure.
- Percent (%) Area Stenosis [ Time Frame: Index Procedure (pre-procedure, post-OAS treatment and post-balloon treatment) ]Percentage (%) of area stenosis as assessed by the intravascular ultrasound (IVUS) Core Lab. Percentage of area stenosis was calculated as 1 - (minimum lumen area / reference lumen area).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938391
|United States, New York|
|NYU School of Medicine|
|New York, New York, United States, 10016|
|Principal Investigator:||Anvar Babaev, MD||NYU Langone Medical Center|