EverFlex Post Approval Study (DURABILITY PAS)
This post-approval study is designed to confirm the long-term safety and effectiveness of the EverFlex™ Self-Expanding Stent System for the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal arteries.
Peripheral Arterial Disease
Lower Extremity Arterial Disease
Device: EverFlex™ Self-Expanding Peripheral Stent System
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The US StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the EverfLex NitInol STent System Post Approval Study|
- Primary Outcome - Composite endpoint [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]Composite endpoint defined as freedom from acute death, freedom from 36-month amputation, and freedom from 36-month clinically-driven target lesion revascularization compared to a PTA performance goal.
|Study Start Date:||September 2012|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
Experimental: Study cohort
All patients enrolled in this study will treated with the EverFlex™ Self-Expanding Peripheral Stent System.
|Device: EverFlex™ Self-Expanding Peripheral Stent System|
|Contact: Stephanie Brucato, CCRA||Stephanie.Brucato@Covidien.com|
|United States, Tennessee|
|Premier Surgical Associates||Recruiting|
|Knoxville, Tennessee, United States, 37909|
|Principal Investigator: Christopher Pollock, MD|
|Principal Investigator:||Jon S Matsumura, MD||University of Wisconsin School of Medicine and Public Health|
|Principal Investigator:||Krishna Rocha-Singh, MD||Priarie Heart Institute|