Bard® LifeStent® Vascular Stent Delivery System Study
The purpose of this study is to evaluate the effectiveness and safety of a new delivery system for the Bard® LifeStent® Vascular Stent System.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Bard® LifeStent® Vascular Stent Delivery System Study|
- (Deployment Success) Post-deployment stent length, measured during procedure directly at pre- and post-stent implantation time point [ Time Frame: At implantation (Day 0) ] [ Designated as safety issue: No ]
Acute effectiveness defined as the successful delivery of the stent with the post-deployment stent length being within 10% of the pre-deployment length.
- (Safety) Freedom from occurrence of death, amputation and TVR/TLR at 30-days post-index procedure. [ Time Frame: 30 day follow-up ] [ Designated as safety issue: Yes ]
Freedom from occurrence of death, amputation and TVR/TLR at 30-days post-index procedure.
- Primary Target Lesion Patency [ Time Frame: 12 months post-index procedure ] [ Designated as safety issue: No ]Primary Target Lesion Patency (TLP) at 12 months post-index procedure compared to PTA.
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||October 2013|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Device: Bard® LifeStent® Vascular Stent System
Single-arm, non-randomized, prospective, multi-center study using the Bard® LifeStent® Vascular Stent Delivery System in subjects with lifestyle-limiting claudication or ischemic rest pain that are candidates for percutaneous transluminal angioplasty (PTA) and stenting with lesion(s) in the infra-inguinal segment (superficial femoral artery (SFA) and/or proximal popliteal artery). Subjects will be treated with PTA followed by implantation of the Bard® LifeStent® Vascular Stent.
Clinical follow-up for all subjects will be performed prior to hospital discharge, 30-days, and 12-, 24-, and 36-months post-index procedure.
|Univ. Prof. Dr. Johannes Lammer|
|Vienna, Austria, 1090|
|Herzzentrum Bad Krozingen|
|Bad Krozingen, Baden Württemberg, Germany, 79189|
|Dr. Henrik Schroeder|
|Berlin, Germany, 13347|
|Dr. Hans Krankenberg|
|Hamburg, Germany, 22527|
|Dr. Rainer Schmiedel|
|Kaiserslautern, Germany, 67657|
|Prof. Dr. med. Dietrich Pfeiffer|
|Leipzig, Germany, 04103|
|Prof. Dr. Holger Reinecke|
|Münster, Germany, 48149|
|Prof. Dr. Gunnar Tepe|
|Rosenheim, Germany, 83022|
|Principal Investigator:||Thomas Zeller, MD||Herzzentrum Bad Krozingen, Germany|