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.
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.
Study Type
OBSERVATIONAL
Enrollment
259
Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent
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
...and 4 more locations
Number of Participants With Target Vessel Patency
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.
Time frame: 12 months
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