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Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System

NCT01355406 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 257

Last updated 2018-06-29

No results posted yet for this study

Summary

This is a clinical study of a new self-expanding stent (FlexStent®) designed specifically to cope with the extreme demands of the superficial femoral artery (SFA)/proximal popliteal artery. The arteries are often abbreviated as femoropopliteal.

The intent of this study is to demonstrate that the FlexStent® Femoropopliteal Self-Expanding Stent System is safe and effective for the treatment of patients with peripheral arterial disease. Specifically, the FlexStent® shall meet or exceed the proposed safety and efficacy performance goals established for Femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease.

Conditions

Interventions

DEVICE

FlexStent® Femoropopliteal Self Expanding Stent System

Transcatheter over guidewire placement of an intravascular stent(s)

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • Prairie Education and Research Cooperative

    collaborator INDUSTRY

  • Cordis Corporation

    lead INDUSTRY

Principal Investigators

  • William A. Gray, MD · Center for Interventional Vascular Therapy / Columbia University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-16
Primary Completion
2016-01-15
Completion
2018-04-10

Countries

  • United States
  • Belgium

Study Locations

More Related Trials

Entities

Diseases

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 NCT01355406 on ClinicalTrials.gov