Trials / Completed
CompletedNCT01263665
Evaluation of the 25 Centimeter (cm) GORE® VIABAHN® Endoprosthesis
Evaluation of the 25 Centimeter (cm) GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface to Treat de Novo and/or Restenotic Lesions of the Superficial Femoral Artery (SFA)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 71 (actual)
- Sponsor
- W.L.Gore & Associates · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to confirm the safety and performance of the 25 cm GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface when used in the Superficial Femoral Artery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 25 cm GORE® VIABAHN® | 25 cm GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface, possibly in conjunction with an additional overlapping VIABAHN® device (2.5, 5, 10, 15, or 25 cm lengths) based on the enrolled patient's lesion length (greater than or equal to 20 cm length). |
Timeline
- Start date
- 2010-12-01
- Primary completion
- 2012-08-01
- Completion
- 2015-11-01
- First posted
- 2010-12-21
- Last updated
- 2015-12-17
- Results posted
- 2014-02-24
Source: ClinicalTrials.gov record NCT01263665. Inclusion in this directory is not an endorsement.