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

Brief Title

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

Official Title

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

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.
    

Study Type

Observational [Patient Registry]

Primary Outcome

Target vessel patency (patient level)

Secondary Outcome

 Reintervention (total and reintervention that can be attributed to branches originally treated with the VBX Stent Graft)

Condition

Abdominal Aortic Aneurysm

Intervention

GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

Study Arms / Comparison Groups

 fEVAR

Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Device

Estimated Enrollment

260

Start Date

March 23, 2022

Completion Date

July 2026

Primary Completion Date

June 30, 2023

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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Luca Bertoglio, Prof, +393463645539, [email protected]

Location Countries

Denmark

Location Countries

Denmark

NCT ID

NCT05143138

Organization ID

VBX 21-04

Responsible Party

Sponsor

Study Sponsor

W.L.Gore & Associates

Study Sponsor

Luca Bertoglio, Prof, Principal Investigator, spedali civili brescia

Verification Date

February 2023