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

Last updated: January 22, 2025
Sponsor: W.L.Gore & Associates
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Heart Disease

Aneurysm

Cardiovascular Disease

Treatment

GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

Clinical Study ID

NCT05143138
VBX 21-04
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as aBridging Stent in conjunction with a branched/fenestrated stent graft to allowendovascular 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 tolocal regulations.

Exclusion

Exclusion Criteria:

  1. Patient treated for ruptured aneurysm or who were otherwise hemodynamically unstableat 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 techniqueper the pre-treatment case plan

  5. At the time of treatment, patient had known coagulation disorders includinghypercoagulability 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 ofdevice implant, that can confound the registry endpoints.

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

Study Design

Total Participants: 259
Treatment Group(s): 1
Primary Treatment: GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
Phase:
Study Start date:
March 23, 2022
Estimated Completion Date:
July 31, 2026

Study 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.

Connect with a study center

  • Aarhus University

    Aarhus, 8200
    Denmark

    Site Not Available

  • Rigshospitalet

    Copenhagen, 2100
    Denmark

    Site Not Available

  • IRCCS Ospedale Policlinico San Martino

    Genova, 16132
    Italy

    Site Not Available

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

    Milano, 20132
    Italy

    Site Not Available

  • Azienda Ospedaliera Complesso Ospedaliero San Giovanni Addolorata

    Roma, 00184
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Policlinico Umberto I

    Roma,
    Italy

    Site Not Available

  • AMC, Meibergdreef 9

    Amsterdam, 1105
    Netherlands

    Site Not Available

  • Haukeland Universitetssjukehus

    Bergen, 5021
    Norway

    Site Not Available

  • UNN Tromsø

    Tromsø, 9038
    Norway

    Site Not Available

  • St. Olavs Hospital

    Trondheim,
    Norway

    Site Not Available

  • Hospital Clínico Universitario San Cecilio

    Granada, 18016
    Spain

    Site Not Available

  • Hospital Clinico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Skane University Hospital

    Malmö, 214 28
    Sweden

    Site Not Available

  • Uppsala University Hospital

    Uppsala, S-751 85
    Sweden

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.