Trials / Completed
CompletedNCT00228384
GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study
GORE VIABAHN Endoprosthesis Versus Bare Nitinol Stent in the Treatment of Long Lesion (>8cm) Superficial Femoral Artery Occlusive Disease
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 148 (actual)
- Sponsor
- W.L.Gore & Associates · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the performance of the GORE VIABAHN® Endoprosthesis compared to a bare nitinol stent for the treatment of superficial femoral artery (SFA) occlusive disease in long lesions.
Detailed description
This is a multicenter, prospective, randomized study with clinical and radiographic follow-up for three years post-procedure. Approximately one hundred fifty subjects will be enrolled and randomized into one of two study treatment groups.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | GORE VIABAHN Endoprosthesis | Implantation |
| DEVICE | Bare Nitinol Stent | Implantation |
Timeline
- Start date
- 2005-09-01
- Primary completion
- 2011-01-01
- Completion
- 2011-01-01
- First posted
- 2005-09-28
- Last updated
- 2012-06-04
- Results posted
- 2012-05-28
Locations
15 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00228384. Inclusion in this directory is not an endorsement.