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

NCT ID: NCT05143138

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 259 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-23
• Study Completion Date: 2026-12-31

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.

Conditions

Abdominal Aortic Aneurysm; Thoracic Aortic Aneurysm

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Study Groups

fEVAR

Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a fenestrated stent graft to allow endovascular aneurysm repair

GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

Intervention Type: DEVICE

Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent

bEVAR

Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched stent graft to allow endovascular aneurysm repair

GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

Intervention Type: DEVICE

Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent

fEVAR and bEVAR

Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched and fenestrated stent graft to allow endovascular aneurysm repair

GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

Intervention Type: DEVICE

Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent

Interventions

GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 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

2. Age ≥18 years at the time of implant

3. 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

1. Patient treated for ruptured aneurysm or who were otherwise hemodynamically unstable at the time of the procedure

2. Patient treated for acute or sub-acute dissection, <90 days from onset of symptoms

3. Patient treated using physician-modified endovascular grafts

4. Patient intended to be treated with chimney, periscope, octopus, sandwich technique per the pre-treatment case plan

5. At the time of treatment, patient had known coagulation disorders including hypercoagulability that were not amenable to treatment

6. Patient was pregnant at the time of treatment.

7. Participation in another drug or device investigational study within one year of device implant, that can confound the registry endpoints.

8. Patient had known or suspected systemic infection (including treatment for mycotic aneurysm) at the time of implant.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

W.L.Gore & Associates

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luca Bertoglio, Prof

Role: PRINCIPAL_INVESTIGATOR

spedali civili brescia

Locations

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

Malmo, , Sweden

Uppsala University Hospital

Uppsala, , Sweden

Countries

Denmark; Italy; Netherlands; Norway; Spain; Sweden

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

VBX 21-04

Identifier Type: -

Identifier Source: org_study_id