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 (EMBRACE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Thoracic Aortic Aneurysm; Abdominal Aortic Aneurysm
• Intervention / Treatment: Device: GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

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
• Enrollment (Actual): 259

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus University
  • Copenhagen, Denmark, 2100
    • Rigshospitalet
• Italy
  • Genova, Italy, 16132
    • IRCCS Ospedale Policlinico San Martino
  • Milano, Italy, 20132
    • "Vita-Salute" San Raffaele University I.R.C.C.S Ospedale San Raffaele
  • Roma, Italy, 00184
    • Azienda Ospedaliera Complesso Ospedaliero San Giovanni Addolorata
  • Roma, Italy
    • Azienda Ospedaliera Universitaria Policlinico Umberto I
• Netherlands
  • Amsterdam, Netherlands, 1105
    • AMC, Meibergdreef 9
• Norway
  • Bergen, Norway, 5021
    • Haukeland Universitetssjukehus
  • Tromsø, Norway, 9038
    • UNN Tromsø
  • Trondheim, Norway
    • St. Olavs hospital
• Spain
  • Granada, Spain, 18016
    • Hospital Clinico Universitario San Cecilio
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
• Sweden
  • Malmö, Sweden, 214 28
    • Skåne University Hospital
  • Uppsala, Sweden, S-751 85
    • Uppsala University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Other

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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	Device: GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis; 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	Device: GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis; Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reintervention (total and reintervention that can be attributed to branches originally treated with the VBX Stent Graft)	Any repeated vascular or nonvascular procedure related to the index procedure	12 months and annually through 5 years post-implant
Target Vessel Technical Success	Successful catheterization and VBX Stent Graft placement in all intended target vessels	at the procedure
Primary Technical Success (Total Endovascular Procedure)	A modified technical success definition, requiring the following: Successful side branch catheterization and placement of bridging stents with restoration and maintenance of flow in all intended target vessels; Patency of all aortic modular stent graft components and intended side branch components; 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)	at the procedure
Target vessel instability	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	12 months and annually through 5 years post-implant
Target vessel patency (patient level)	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.	annually from 2-5 years post-implant
Target vessel patency (vessel level analysis)	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.	annually from procedure to 5 years post-implant
Aneurysm-related mortality	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	at 12 months and annually through 5 years post-implant
MAEs at 30 days	MAEs according to stardard definition.	30 days post implant

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: Luca Bertoglio, Prof, Spedali Civili Brescia

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2022
• Primary Completion (Actual): April 30, 2024
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 19, 2021
• First Submitted That Met QC Criteria: November 19, 2021
• First Posted (Actual): December 3, 2021

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 21, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracic
• Other Study ID Numbers: VBX 21-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes