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

NCT03071146 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2018-08-21

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • C. R. Bard

    lead INDUSTRY

Principal Investigators

  • Thomas Zeller, MD · Universitaets-Herzzentrum Freiburg, Bad Krozingen

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-15
Primary Completion
2017-05-04
Completion
2018-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03071146 on ClinicalTrials.gov