Trials / Completed
CompletedNCT01355406
Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System
Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 257 (actual)
- Sponsor
- Cordis US Corp. · Industry
- Sex
- All
- Age
- 35 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DEVICE | FlexStent® Femoropopliteal Self Expanding Stent System | Transcatheter over guidewire placement of an intravascular stent(s) |
Timeline
- Start date
- 2011-09-16
- Primary completion
- 2016-01-15
- Completion
- 2018-04-10
- First posted
- 2011-05-18
- Last updated
- 2018-06-29
Locations
38 sites across 2 countries: United States, Belgium
Source: ClinicalTrials.gov record NCT01355406. Inclusion in this directory is not an endorsement.