Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used as a Bridging Stent With Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries (EMBRACE)
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- STATUS
- Recruiting
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- End date
- Jul 26, 2026
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- participants needed
- 260
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- sponsor
- W.L.Gore & Associates
Summary
Multicenter, single-arm retrospective and prospective registry is being conducted to confirm the clinical performance and safety of GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis when used as a Bridging Stent with Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries.
Description
Up to 15 sites in Europe will be required to enroll a minimum of 220 patients that have had treatment with GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis when used as a Bridging Stent with Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries.
The registry procedures consist of two phases, retrospective phase and prospective phase.
The retrospective phase consists only of the collection of retrospective data (baseline, treatment and FU data) from the source documents available at the site from the time of the treatment until the enrollment date (ICF signature).
The prospective phase consists in collection of follow-up visits from the enrollment up to 5 years. The FU data collected prospectively can change from subject to subject depending on the index procedure date. Diagnostic imaging, treatment interventions, and follow up will be determined by physicians based on clinical practice standards.
Details
| Condition | Abdominal Aortic Aneurysm, Thoracic Aortic Aneurysm |
|---|---|
| Treatment | GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis |
| Clinical Study Identifier | NCT05143138 |
| Sponsor | W.L.Gore & Associates |
| Last Modified on | 26 April 2022 |
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