NL-OMON51685
Recruiting
Not Applicable
EndurAnt Stent Graft system vs ExcluDer endoprothesis: a global, prospectiVe, rANdomized Clinical trial in sac rEgression (ADVANCE Study) - ADVANCE study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- repair of abdominal aortic aneurysm
- Sponsor
- Medtronic B.V.
- Enrollment
- 80
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria:
- •Subjects must meet ALL of the following 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
- •o \>\= 5 cm (if woman)
Exclusion Criteria
- •Subjects are NOT eligible for trial participation if they meet ANY of the
- •following 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 trial
- •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
Outcomes
Primary Outcomes
Not specified
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