NCT01179984

Bard® LifeStent® Vascular Stent Delivery System Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Peripheral Vascular Disease

Interventions

Type	Name	Description
DEVICE	Bard® LifeStent® Vascular Stent System	Stent Implantation

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-10-01
• Completion: 2013-12-01
• First posted: 2010-08-11
• Last updated: 2018-11-08
• Results posted: 2017-03-09

Locations

8 sites across 2 countries: Austria, Germany