Popliteal Artery of Treatment With Balloon Angioplasty vs. SUPERA VERITAS Peripheral Stent System (PARADIGM)
|ClinicalTrials.gov Identifier: NCT01667393|
Recruitment Status : Withdrawn
First Posted : August 17, 2012
Last Update Posted : June 18, 2015
Information provided by (Responsible Party):
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.
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Vascular Disease.||Device: IDEV SUPERA Stent Device: Percutaneous Transluminal Angioplasty||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Popliteal Artery Trial of Patients Undergoing Treatment With Balloon Angioplasty vs. the Adaptive SUPERA VERITAS Peripheral Stent System|
|Study Start Date :||January 2013|
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|
Primary Outcome Measures :
- Primary patency [ Time Frame: 12 months ]Primary efficacy will be target lesion primary patency at 12 months.
Secondary Outcome Measures :
- MAE-free survival rate. [ Time Frame: 12 months ]Major Adverse Event-free survival rate that is non-inferior to that of PTA at 12 months.
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