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

Active, not recruiting

Brief 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.

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method

Locations (14): Aarhus University
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Aarhus, Denmark
Rigshospitalet
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Copenhagen, Denmark
IRCCS Ospedale Policlinico San Martino
🇮🇹
Genova, Italy
"Vita-Salute" San Raffaele University I.R.C.C.S Ospedale San Raffaele
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Milano, Italy
Azienda Ospedaliera Complesso Ospedaliero San Giovanni Addolorata
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Roma, Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I
🇮🇹
Roma, Italy
AMC, Meibergdreef 9
🇳🇱
Amsterdam, Netherlands
Haukeland Universitetssjukehus
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Bergen, Norway
UNN Tromsø
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Tromsø, Norway
St. Olavs Hospital
🇳🇴
Trondheim, Norway
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Aarhus University
🇩🇰Aarhus, Denmark