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

• Conditions: Thoracic Aortic Aneurysm; Abdominal Aortic Aneurysm
• Interventions: Device: GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

• Registration Number: NCT05143138
• Lead Sponsor: W.L.Gore & Associates

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 Timeline

• Study First Submitted: 2021-11-19
• Study First Submitted QC: 2021-11-19
• Study First Posted: 2021-12-03
• Study Start: 2022-03-23
• Primary Completion: 2024-04-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-27
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 259

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
fEVAR	GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis	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
fEVAR and bEVAR	GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis	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
bEVAR	GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis	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

Primary Outcome Measures

Name	Time	Method
Target vessel patency (patient level)	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.

Secondary Outcome Measures

Name	Time	Method
Primary Technical Success (Total Endovascular Procedure)	at the procedure	A modified technical success definition, requiring the following: 1. Successful side branch catheterization and placement of bridging stents with restoration and maintenance of flow in all intended target vessels; 2. Patency of all aortic modular stent graft components and intended side branch components; 3. Absence of type I or type III endoleaks at completion angiography that extends beyond 30 days by confirmatory imaging (CTA, magnetic resonance angiography \[MRA\], or duplex ultrasound)
Target vessel patency (vessel level analysis)	annually from procedure to 5 years post-implant	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.
Reintervention (total and reintervention that can be attributed to branches originally treated with the VBX Stent Graft)	12 months and annually through 5 years post-implant	Any repeated vascular or nonvascular procedure related to the index procedure
Target Vessel Technical Success	at the procedure	Successful catheterization and VBX Stent Graft placement in all intended target vessels
Target vessel instability	12 months and annually through 5 years post-implant	Death or rupture related to side branch complication (e.g., endoleak) or reintervention to treat a branch-related complication, including endoleak, disconnection, kink, stenosis, occlusion, or rupture
Aneurysm-related mortality	at 12 months and annually through 5 years post-implant	Any death that occurs within the first 30 days or any death that results from aneurysm rupture, aorta-related complications (eg, infection, occlusion, dissection, hematoma), or a complication of a secondary intervention
Target vessel patency (patient level)	annually from 2-5 years post-implant	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.
MAEs at 30 days	30 days post implant	MAEs according to stardard definition.

Trial Locations

Locations (14)

AMC, Meibergdreef 9; 🇳🇱 Amsterdam, Netherlands

Aarhus University; 🇩🇰 Aarhus, Denmark

IRCCS Ospedale Policlinico San Martino; 🇮🇹 Genova, Italy

"Vita-Salute" San Raffaele University I.R.C.C.S Ospedale San Raffaele; 🇮🇹 Milano, Italy

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Azienda Ospedaliera Complesso Ospedaliero San Giovanni Addolorata; 🇮🇹 Roma, Italy

Azienda Ospedaliera Universitaria Policlinico Umberto I; 🇮🇹 Roma, Italy

UNN Tromsø; 🇳🇴 Tromsø, Norway

Hospital Clínico Universitario San Cecilio; 🇪🇸 Granada, Spain

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden

Skane University Hospital; 🇸🇪 Malmö, Sweden

Haukeland Universitetssjukehus; 🇳🇴 Bergen, Norway

St. Olavs Hospital; 🇳🇴 Trondheim, Norway