Active — Not RecruitingNot Applicable

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

Denmark, Italy259 participantsStarted 2022-03-23

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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 intended to be treated with chimney, periscope, octopus, sandwich technique per the pre-treatment case plan
✕. At the time of treatment, patient had known coagulation disorders including hypercoagulability that were not amenable to treatment
✕. Patient was pregnant at the time of treatment.
✕. Participation in another drug or device investigational study within one year of device implant, that can confound the registry endpoints.
✕. Patient had known or suspected systemic infection (including treatment for mycotic aneurysm) at the time of implant.

What they're measuring

Number of Participants With Target Vessel Patency

Timeframe: 12 months

Trial details

NCT IDNCT05143138

SponsorW.L.Gore & Associates

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-04-30

Results submitted2025-06-11

View on ClinicalTrials.gov More Abdominal Aortic Aneurysm trials