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Starting soon Observational

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

NCT07480395 · tracked via the Priya Life Science UK tracker
Phase
Observational
Started
2026-12
Last updated
2026-10-23

Condition(s) studied

Complex Aortic AneurysmsThoracoabdominal AneurysmFenestrated Endovascular Aortic RepairEndovascular Aortic RepairAbdominal Aorta AneurismChronic Dissection

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 six (6) 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 not associated with registry procedure. 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

Primary outcome measure(s)

  • Freedom from Target Vessel Instability — through 1 year Follow-up
    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

Trial sites (26)

FacilityCityRegionStatus
Medical University Innsbruck Innsbruck Austria
Medizinische Universität Wien Vienna Austria
Rigshospitalet University Hospital Copenhagen Denmark
Universitäts-Herzzentrum Bad Krozingen Bad Krozingen Germany
University Medical Center Hamburg-Eppendorf Hamburg Germany
University of Heidelberg Heidelberg Germany
Helios Hospital München West München Germany
LMU Klinikum Campus Großhadern München Germany
Laiko General Hospital of Athens Athens Greece
Larissa University Hospital Larissa Greece
Policlinico di Sant'Orsola Bologna Italy
ASST Spedali Civili di Brescia Brescia Italy
Arcispedale Sant'Anna Ferrara Italy
AOU Padova Padova Italy
AOU Policlinico Umberto I Roma Italy
Amsterdam UMC Amsterdam Netherlands
Elisabeth-Tweesteden Hospital Tilburg Netherlands
Complejo Hospitalario Universitario de La Coruña A Coruña Spain
Hospital Clinico San Carlos Madrid Spain
Skåne University Hospital Malmö Sweden
Karolinska University Hospital Stockholm Sweden
University Hospital Basel Basel Switzerland
University Hospital Bern Bern Switzerland
University Hospital Birmingham Birmingham United Kingdom
St Thomas Hospital London United Kingdom
Manchester Royal Infirmary Manchester United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07480395 on ClinicalTrials.gov ↗ ← All trials in the UK