Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
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Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- W.L.Gore & Associates
- Azonosító
- NCT07480395
- A regiszteradat frissítve
- 2026. október 23.
- Eredeti leírás
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 perfusionA teljes eredeti leírásKevesebb
The ENVISION Registry: REal-World Data CollectioN of GORE deVIceS Used In the endOvascular treatmeNt of Aortic Aneurysms Which Incorporate Visceral Arteries.
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
Bevonási feltételek: 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.
Kizáró feltételek: Patient has a prior visceral artery stenting not associated with registry procedure; 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 treated for acute or sub-acute dissection, <90 days from onset of symptoms; Patient has a life expectancy < 1-year; Patient is participating in an investigational study which may confound registry results, unless approved by Gore.