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
Condition(s) studied
Investigational drug(s) / intervention(s)
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis: Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent
Study 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.
Eligibility
Primary outcome measure(s)
- Number of Participants With Target Vessel Patency — 12 months
Uninterrupted patency with no occlusion or procedure performed to maintain patency on the VBX Stent Graft or native target vessel. Interventions intended to treat endoleak or stent disconnection do not count as loss of primary patency. Binomial proportions were calculated at 12 month follow-up.
Trial sites (14)
| Facility | City | Region | Status |
|---|---|---|---|
| Aarhus University | Aarhus | Denmark | |
| Rigshospitalet | Copenhagen | Denmark | |
| IRCCS Ospedale Policlinico San Martino | Genova | Italy | |
| "Vita-Salute" San Raffaele University I.R.C.C.S Ospedale San Raffaele | Milan | Italy | |
| Azienda Ospedaliera Complesso Ospedaliero San Giovanni Addolorata | Roma | Italy | |
| Azienda Ospedaliera Universitaria Policlinico Umberto I | Roma | Italy | |
| AMC, Meibergdreef 9 | Amsterdam | Netherlands | |
| Haukeland Universitetssjukehus | Bergen | Norway | |
| UNN Tromsø | Tromsø | Norway | |
| St. Olavs Hospital | Trondheim | Norway | |
| Hospital Clínico Universitario San Cecilio | Granada | Spain | |
| Hospital Clinico San Carlos | Madrid | Spain | |
| Skane University Hospital | Malmö | Sweden | |
| Uppsala University Hospital | Uppsala | Sweden |
More W.L.Gore & Associates trials in Sweden
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05143138 on ClinicalTrials.gov ↗ ← All trials in Sweden