Clinical Trials in the UK / NCT07480395
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
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More W.L.Gore & Associates trials in the UK
Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry
Active, not recruiting
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