Bard® LifeStent® Vascular Stent Delivery System Study

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness and safety of a new delivery system for the Bard® LifeStent® Vascular Stent System.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01179984
Study type	Interventional
Source	C. R. Bard
Contact
Status	Completed
Phase	N/A
Start date	June 2010
Completion date	December 2013

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