Popliteal Artery of Treatment With Balloon Angioplasty vs. SUPERA VERITAS Peripheral Stent System (PARADIGM)
Unblinded, randomized, balanced trial comparing 12 month target lesion patency rates of the IDEV SUPERA VERITAS peripheral stent system to PTA in the treatment of obstructive atherosclerotic popliteal artery disease.
Peripheral Vascular Disease.
Device: IDEV SUPERA Stent
Device: Percutaneous Transluminal Angioplasty
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Popliteal Artery Trial of Patients Undergoing Treatment With Balloon Angioplasty vs. the Adaptive SUPERA VERITAS Peripheral Stent System|
- Primary patency [ Time Frame: 12 months ] [ Designated as safety issue: No ]Primary efficacy will be target lesion primary patency at 12 months.
- MAE-free survival rate. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Major Adverse Event-free survival rate that is non-inferior to that of PTA at 12 months.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Experimental: IDEV SUPERA Stent
Following PTA of the target lesion, the SUPERA stent will be delivered to the treated segment.
|Device: IDEV SUPERA Stent|
Active Comparator: Percutaneous Transluminal Angioplasty
The target lesion will be treated by PTA alone.
|Device: Percutaneous Transluminal Angioplasty|
|Contact: Carol C Base, BSN, MSfirstname.lastname@example.org|