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

NCT05143138 | Active Not Recruiting Results DMC FDA Device

• 1 other identifier: VBX 21-04
• Study Type: observational
• Target: 259
• Locations: 6 countries
• Sites: 14

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.

Conditions

Abdominal Aortic Aneurysm; Thoracic Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Study Arms (3)

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

Device: GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

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

Device: GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

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

Device: GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

Interventions

GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis DEVICE

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

bEVAR; fEVAR; fEVAR and bEVAR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The registry has been designed with broad eligibility criteria to capture real-world data about GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis used as a Bridging Stent in conjunction with a branched/fenestrated stent graft to allow endovascular aneurysm repair. Patients will be identified from hospital database.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (14)

Aarhus University

Aarhus, 8200, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

IRCCS Ospedale Policlinico San Martino

Genova, 16132, Italy

Location

"Vita-Salute" San Raffaele University I.R.C.C.S Ospedale San Raffaele

Milan, 20132, Italy

Location

Azienda Ospedaliera Complesso Ospedaliero San Giovanni Addolorata

Roma, 00184, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Umberto I

Roma, Italy

Location

AMC, Meibergdreef 9

Amsterdam, 1105, Netherlands

Location

Haukeland Universitetssjukehus

Bergen, 5021, Norway

Location

UNN Tromsø

Tromsø, 9038, Norway

Location

St. Olavs Hospital

Trondheim, Norway

Location

Hospital Clínico Universitario San Cecilio

Granada, 18016, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Skane University Hospital

Malmo, 214 28, Sweden

Location

Uppsala University Hospital

Uppsala, S-751 85, Sweden

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Results Point of Contact

• Title: Cinzia Santin, Clinical Study Mgt, Gore Medical Products
• Organization: WL Gore

csantin@wlgore.com

+393463645539

Study Officials

• Luca Bertoglio, Prof

  spedali civili brescia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 3, 2021
• Study Start: March 23, 2022
• Primary Completion: April 30, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 22, 2025
• Results First Posted: August 22, 2025

Record last verified: 2025-06

Locations

NL (1); NO (3); DK (2); ES (2); SE (2); IT (4)