Popliteal Artery of Treatment With Balloon Angioplasty vs. SUPERA VERITAS Peripheral Stent System (PARADIGM)
This study has been withdrawn prior to enrollment.
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.
|Peripheral Vascular Disease.||Device: IDEV SUPERA Stent Device: Percutaneous Transluminal Angioplasty||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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|
Resource links provided by NLM:
Further study details as provided by Abbott Vascular:
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.
|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|
Contacts and Locations
No Contacts or Locations Provided