Endurant CHevAr New Indication Trial: ENCHANT
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A vizsgálat adatai
- Ki végzi
- Medtronic Cardiovascular
- Azonosító
- NCT03320252
- A regiszteradat frissítve
- 2026. június 2.
- Eredeti leírás
The purpose of the post-market study is to assess the clinical outcomes, safety, and performance of the Endurant Chimney Graft Technique (Endurant Stent Graft Systems used with a balloon-expandable covered stent graft) for treatment of juxtarenal aortic aneurysms with a short infrarenal neck in a real world setting.A teljes eredeti leírásKevesebb
Endurant CHevAr New Indication Trial: ENCHANT - Post-market Study of the Endurant CHEVAR Technique for the Treatment of Juxtarenal Aortic Aneurysms With a Short Infrarenal Neck
The purpose of the post-market study is to assess the clinical outcomes, safety, and performance of the Endurant Chimney Graft Technique (Endurant Stent Graft Systems used with a balloon-expandable covered stent graft) for treatment of juxtarenal aortic aneurysms with a short infrarenal neck in a real world setting.
Bevonási feltételek: Subject is ≥18 years old; Subject is scheduled for primary treatment of the juxtarenal aortic aneurysm with a short infrarenal neck (i.e. no revision subjects); Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements; Subject has provided written informed consent; Subject is an eligible candidate according to the currently available Endurant II/IIs instructions for use for ChEVAR; Subject has a juxtarenal aortic aneurysm with a short infrarenal neck (definition of juxtarenal aortic aneurysm with a short infrarenal neck will be in accordance with commercially available Endurant II/IIs instructions for use for ChEVAR).
Kizáró feltételek: Subject is participating in a concurrent study which may confound study results; Subject has previously undergone surgical treatment for abdominal aortic aneurysm; Subject has an active COVID-19 infection or relevant history of COVID-19. Relevant history of COVID-19 is defined as availability of a positive COVID-19 test with sequela or hospitalization for treatment of COVID-19. Subjects with a positive COVID-19 test who were asymptomatic or had mild symptoms should be excluded only if the positive test was less than 6 months prior to enrollment; Subject has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment; Subject has a creatinine level >2.0 mg/dl (or >176.8 μmol/L) and/or is on dialysis; Subject has a life expectancy ≤ 2 year; Subject has an aneurysm that is:; Suprarenal or pararenal; Isolated iliofemoral; Mycotic; Inflammatory; Pseudoaneurysm; Subject requires emergent aneurysm treatment, for example, trauma or rupture; Subject is a female of childbearing potential in whom pregnancy cannot be excluded.