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Clinical Trials/JPRN-jRCTs032220706
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.

Registry
who.int
Start Date
March 15, 2023
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Shimizu Hideyuki

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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