Trials / Completed
CompletedNCT02080871
A Study of the Gore VIABAHN BX for Treatment of Occlusive Disease in the Iliac Arteries.
Evaluation of the Gore(R) Viabahn(R) Balloon Expandable Endoprosthesis (VIABAHN BX) for the Treatment of Occlusive Disease in the Common and External Iliac Arteries.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 134 (actual)
- Sponsor
- W.L.Gore & Associates · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Evaluation of the Gore(R) VIABAHN BX for the treatment of arterial occlusive disease in the common and/or external iliac arteries.
Detailed description
This study is a prospective, multicenter, non-randomized single-arm clinical study to evaluate the safety and efficacy of the VIABAHN BX for the treatment of arterial occlusive disease in patients with de novo or restenotic lesions in the common and/or external iliac arteries.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Stenting of the Common and/or External Iliac Arteries | Balloon expandable stenting of iliac occlusive disease. |
Timeline
- Start date
- 2014-07-01
- Primary completion
- 2016-05-01
- Completion
- 2018-10-01
- First posted
- 2014-03-06
- Last updated
- 2019-01-16
- Results posted
- 2018-07-17
Locations
27 sites across 2 countries: United States, New Zealand
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02080871. Inclusion in this directory is not an endorsement.