Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.

NCT07480395 | Not Yet Recruiting

• 1 other identifier: VSC 25-08
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

The registry population consists of patients presenting with complex aortic pathologies amenable to endovascular aortic repair that requires the incorporation of bridging stents to maintain visceral artery perfusion

Conditions

Chronic Dissection; Complex Aortic Aneurysms; Thoracoabdominal Aneurysm; Fenestrated Endovascular Aortic Repair; Endovascular Aortic Repair; Abdominal Aorta Aneurism

Keywords

FEVAR; BEVAR; TAAA; AAA; Visceral; aortic aneurysm; PMEGs

Outcome Measures

Primary Outcomes (1)

• Freedom from Target Vessel Instability

  Freedom from any death or rupture related to side branch complication (e.g., endoleaks, rupture); any branch occlusion; or any secondary intervention indicated to treat a branch-related complication, including endoleaks, disconnection, kink, stenosis, occlusion, or rupture

  through 1 year Follow-up

Secondary Outcomes (12)

• Target Vessel Technical Success

  At procedure

• Procedural Technical Success

  at procedure

• Clinical Success

  through 5-year follow-up

• Major Adverse Events

  through 5-year follow-up

• Freedom from Aneurysm-Related Mortality

  through 5-year follow-up

Study Arms (3)

FEVAR

Patients who are treated with aortic endografts designed exclusively with fenestrations for incorporation of the visceral arteries with at least one BXB device implanted

BEVAR

Patients who are treated with aortic endografts designed exclusively with directional branches for incorporation of the visceral arteries with at least one BXB device implanted

OTHER

Patients who are treated with other endovascular techniques who required incorporation of BXB as bridging stent (i.e. PMEGs).

Eligibility Criteria

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

Study Population

The registry population consists of patients presenting with complex aortic pathologies amenable to endovascular aortic repair that requires the incorporation of bridging stents to maintain visceral artery perfusion. Patients are eligible to participate in the registry if at least one BXB device is intended to be incorporated (first proximal, connected with aortic main body) to maintain visceral artery perfusion. There are no selection criteria (i.e., inclusion or exclusion criteria) based on main aortic body device used, and to allow better RWD representation of the patient population treated with different aortic component, a cap per main aortic body device has been set.

You may qualify if:

• Informed Consent Form (ICF) is signed by Subject.
• Age ≥ 18 years at time of informed consent signature.
• Patient presents with thoracoabdominal, pararenal, juxtarenal, or short-neck infrarenal aortic pathology suitable for endovascular repair.
• Patient requires the incorporation of ≥ 1 visceral artery and is suitable for use of at least 1 GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (BXB) as a bridging stent (Note: Up to six (6) visceral arteries may be incorporated).
• Patient is willing to adhere to the institutional standard of care follow-up.

You may not qualify if:

• Patient has a prior visceral artery stenting not associated with registry procedure.
• Patient treated for acute or sub-acute dissection, \<90 days from onset of symptoms
• Patient is intended to be treated with a parallel grafting (e.g., chimney, periscope, sandwich) or octopus technique.
• Known hypersensitivity to heparin or a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.
• Patient has known coagulation disorders including hypercoagulability that are not amenable to treatment.
• Patient has a life expectancy \< 1-year.
• Patient is participating in an investigational study which may confound registry results, unless approved by Gore

Sponsors & Collaborators

• W.L.Gore & Associates: lead

MeSH Terms

Conditions

Aortic Aneurysm

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 18, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2035
• Last Updated: June 1, 2026

Record last verified: 2026-03