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NCT06029660
AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
Conditions: Aortic Aneurysm, Abdominal
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 180
Sponsor: Shape Memory Medical, Inc.
Location: University of Alabama Birmingham Birmingham Alabama
Summary
To determine the safety and effectiveness of IMPEDE-FX RapidFill to increase the percentage of subjects with shrinkage of the abdominal aortic aneurysm sac when used as an adjunct to on-label endovascular aneurysm repair (EVAR) stent graft treatment in trial subjects considered candidates for elective EVAR.
Eligibility Criteria
Inclusion Criteria:
1. ≥18 years of age
2. A candidate for elective EVAR of an infrarenal fusiform aortic aneurysm ≥5.5 cm in diameter in men and ≥5.0 cm in women;
3. Thrombus burden (percentage of the AAA sac occupied by thrombus) \
Source: ClinicalTrials.gov (NCT06029660). StuddyBuddy aggregates publicly available trial information.
