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
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Trial details
- Who runs it
- W.L.Gore & Associates
- Trial code
- NCT05143138
- Record updated
- 21 September 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched/fenestrated stent graft to allow endovascular aneurysm repair from 31 December 2021 until 01 January 2017; Age ≥18 years at the time of implant; Provision of informed consent by the patient or next of kin/legal representative (for deceased patients at registry entry, unless a waiver was granted), according to local regulations.
Exclusion: Patient intended to be treated with chimney, periscope, octopus, sandwich technique per the pre-treatment case plan; Participation in another drug or device investigational study within one year of device implant, that can confound the registry endpoints; At the time of treatment, patient had known coagulation disorders including hypercoagulability that were not amenable to treatment; Patient had known or suspected systemic infection (including treatment for mycotic aneurysm) at the time of implant; Patient treated for ruptured aneurysm or who were otherwise hemodynamically unstable at the time of the procedure; Patient treated for acute or sub-acute dissection, <90 days from onset of symptoms; Patient treated using physician-modified endovascular grafts; Patient was pregnant at the time of treatment.