AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
Shape Memory Medical, Inc.
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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) \<50%, based on pre-procedure CTA 4. Maximum Lumen diameter within the AAA sac of ≥40mm. 5. The predicted minimum number of IMPEDE-FX RapidFill Implants for the subject is ≤200. Exclusion Criteria: General 1. An inability to provide informed consent. 2. Enrolled in another clinical study that could interfere with the outcomes being studied in this trial. 3. Unab…
Interventions
- DeviceIMPEDE-FX RapidFill Implants
Filling of the available flow lumen within the AAA sac with IMPEDE-FX RapidFill Implants
- ProcedureEndoVascular Aneurysm Repair
Standard EVAR repair of abdominal aortic aneurysms using a commercially available stent.
Locations (49)
- University of Alabama BirminghamBirmingham, Alabama
- Honor HealthScottsdale, Arizona
- USC KeckLos Angeles, California
- San Diego VA Medical CenterSan Diego, California
- Delray Medical CenterDelray Beach, Florida
- Mt. Sinai Medical CenterMiami Beach, Florida