JPRN-jRCTs032220706
Recruiting
未知
Endurant Stent Graft system vs Excluder endoprosthesis: a global, prospective, randomized clinical trial in sac regression - ADVANCE
Shimizu Hideyuki0 sites550 target enrollmentMarch 15, 2023
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Abdominal Aortic Aneurysms
- Sponsor
- Shimizu Hideyuki
- Enrollment
- 550
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Subject is \>\= 20 years old
- •2\) Subject and the treating physician agree that the subject will return for all required follow\-up visits
- •3\) Subject or legal representative or consultee, as applicable, has consented for study participation and signed the Informed Consent approved by the sponsor and by the Ethics Committee/Institutional Review Board
- •4\) Subject has an aneurysm diameter of
- •\>\= 5 cm (if woman)
- •\>\= 5\.5 cm (if man)
- •5\) Subject's AAA anatomy is appropriate for both Endurant II/IIs Stent Graft System and Gore Excluder/Excluder Conformable AAA Endoprosthesis as per assessment of both treating physician and Core Lab in accordance with the overlapping commercially available IFUs per applicable region.
Exclusion Criteria
- •1\. Subject is participating in an investigational drug or device study which may bias or interfere with
- •the endpoints and follow\-up of this study
- •2\. Subject has an estimated life expectancy of \<\= 3 years as judged by the investigator
- •3\. Subject has an aneurysm that is:
- •a) Suprarenal/pararenal/juxtarenal
- •b) Isolated ilio\-femoral
- •d) Inflammatory
- •e) Pseudoaneurysm
- •f) Concomitant or prior dissection involving the abdominal aorta or iliac arteries
- •g) Ruptured
Outcomes
Primary Outcomes
Not specified
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