NCT03071146

Utility, Safety, and Effectiveness of the Bard LifeStent 5F Vascular Stent System

A Prospective Study of the Performance of the Bard LifeStent 5F Vascular Stent System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The medical device being examined in this study is the Bard® LifeStent® 5F Vascular Stent System. It is intended for use in patients who suffer from peripheral artery disease (PAD). PAD is generally associated with blocked arteries of the legs. The superficial femoral artery (SFA) and popliteal artery are common locations for this problem to develop. The patient may experience pain or discomfort in the leg that occurs when walking or have other complications associated with wound healing. The purpose of this study is to collect information to assess the deliverability, clinical utility, safety and effectiveness of the Bard® LifeStent® 5F Vascular Stent System.

Conditions

• Peripheral Arterial Disease
• Intermittent Claudication

Interventions

Type	Name	Description
DEVICE	Bard® LifeStent® 5F Vascular Stent System	The LifeStent® Vascular Stent is a peripheral stent intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 240 mm in length in the native superficial femoral artery (SFA) and popliteal artery with reference vessel diameters ranging from 4.0 - 6.5 mm.

Timeline

• Start date: 2017-02-15
• Primary completion: 2017-05-04
• Completion: 2018-05-31
• First posted: 2017-03-06
• Last updated: 2018-08-21

Locations

4 sites across 1 country: Germany