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Clinical Trials/NL-OMON54411
NL-OMON54411
Completed
Not Applicable

Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - A Prospective Multicenter Study. - AAA-SHAPE_NLD

Shape Memory Medical0 sites15 target enrollmentTBD
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Conditionsabdominal aortic aneurysmabdominal aortic widening1000318410002363

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
abdominal aortic aneurysm
Sponsor
Shape Memory Medical
Enrollment
15
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Shape Memory Medical

Eligibility Criteria

Inclusion Criteria

  • •1\. \>\=18 years of age.
  • •2\. A candidate for elective EVAR of an infrarenal aortic aneurysm \>\=5\.5 cm in
  • •diameter in men and \>\=5\.0 cm in women.

Exclusion Criteria

  • •1\. An inability to provide informed consent.
  • •2\. Enrolled in another clinical study.
  • •3\. Aortoiliac aneurysm, or concomitant iliac artery ectasia or aneurysm (common
  • •iliac artery diameter \>24 mm) close to the bifurcation and/or that cannot be
  • •adequately sealed.
  • •4\. Patent AAA sac feeding vessels (within the sac) \>4 mm in diameter.
  • •5\. Volume of AAA sac to be filled after stent graft placement \<20 mL or \>135
  • •mL, based on pre\-procedure CTA (i.e., aortic flow volume exclusive of stent
  • •graft volume).
  • •6\. Use of aortic stent grafts other than the Gore Excluder AAA Endoprosthesis,

Outcomes

Primary Outcomes

Not specified

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