NCT05143138

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 259 (actual)
• Sponsor: W.L.Gore & Associates · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Abdominal Aortic Aneurysm
• Thoracic Aortic Aneurysm

Interventions

Type	Name	Description
DEVICE	GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis	Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent

Timeline

• Start date: 2022-03-23
• Primary completion: 2024-04-30
• Completion: 2026-12-01
• First posted: 2021-12-03
• Last updated: 2025-08-22
• Results posted: 2025-08-22

Locations

14 sites across 6 countries: Denmark, Italy, Netherlands, Norway, Spain, Sweden

Regulatory

• FDA-regulated device study