Trials / Active Not Recruiting
Active Not RecruitingNCT04907240
Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry
Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface (VSX) Global Registry
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 614 (estimated)
- Sponsor
- W.L.Gore & Associates · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Collect real-world post-market clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
Detailed description
This is an Observational, prospective, single-arm, multicenter, post-market registry to collect real-world post-market clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) for one of the following indications: Iliac, Superficial Femoral Artery (SFA), Superficial Femoral Artery In-stent restenosis (SFA ISR), Hemodialysis access (AV access), Visceral artery aneurysms (VAA), Trauma/Injury, Popliteal Artery Aneurysms (PAA), or Other. Approximately 35 sites in Europe will participate and a minimum of 614 patients will be enrolled in this registry. All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) will be included and followed through one year for Trauma/Injury and other; three years for VAA; five years for Iliac, SFA, SFA ISR and AV access and ten years for PAA per institutional standard of care.
Conditions
- Peripheral Artery Disease
- Popliteal Aneurysm
- Hemodialysis Access
- Visceral Artery Aneurysms
- Trauma Injury
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) | Intent to treat with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) in the treatment of Peripheral Artery Disease as part of routine clinical practice. |
Timeline
- Start date
- 2021-10-09
- Primary completion
- 2026-10-01
- Completion
- 2035-10-01
- First posted
- 2021-05-28
- Last updated
- 2026-02-02
Locations
26 sites across 9 countries: Belgium, France, Germany, Greece, Italy, Netherlands, Spain, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT04907240. Inclusion in this directory is not an endorsement.