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Real-World Data Collection of the GORE Devices When Used in the Treatment of Aortic Pathologies Which Requires the Incorporation of the Visceral Arteries. | Clinical Trials | Clareo Health

NOT_YET_RECRUITING

Real-World Data Collection of the GORE Devices When Used in the Treatment of Aortic Pathologies Which Requires the Incorporation of the Visceral Arteries.

NCT07480395•W.L.Gore & Associates

View on ClinicalTrials.gov

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

Detailed Description

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Informed Consent Form (ICF) is signed by Subject.
•2. Age ≥ 18 years at time of informed consent signature.
•3. Patient presents with thoracoabdominal, pararenal, juxtarenal, or short-neck infrarenal aortic pathology suitable for endovascular repair.
•4. 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 five (5) visceral arteries may be incorporated).
•5. Patient is willing to adhere to the institutional standard of care follow-up.

Exclusion Criteria

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

Key Dates

Start Date

December 1, 2026

Primary Completion Date

December 1, 2031

Completion Date

December 1, 2035

Last Updated

March 18, 2026

Enrollment

400

ESTIMATED participants

Conditions

Complex Aortic AneurysmsThoracoabdominal AneurysmFenestrated Endovascular Aortic RepairEndovascular Aortic RepairAbdominal Aorta Aneurism

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NCT06969729

Abdominal Aortic AneurysmJuxtarenal Aortic Aneurysm+2 more

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ACTIVE_NOT_RECRUITINGNA

Visceral Manifold and Unitary Device Study for the Repair of Thoracoabdominal Aortic Aneurysms

NCT02294435

Thoracoabdominal Aneurysms

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Real-World Data Collection of the GORE Devices When Used in the Treatment of Aortic Pathologies Which Requires the Incorporation of the Visceral Arteries.

Inclusion Criteria

Exclusion Criteria

Evaluation of Clinical Efficacy and Safety of Aortal Stent-Graft Created Using 3D Printing Technology

Visceral Manifold and Unitary Device Study for the Repair of Thoracoabdominal Aortic Aneurysms

Evaluating Monitoring Techniques for Postoperative Spinal Cord Ischemia

Changes in Renal Artery Movement Due to Respiration Before and After Fenestrated Endovascular Repair