NCT06029660
AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
Active, Not Recruiting
NAAges 18+InterventionalTreatmentShape Memory Medical, Inc.
~180 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:IMPEDE-FX RapidFill ImplantsEndoVascular Aneurysm Repair
At a glance
Recruiting sites
0 of 49 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Effectiveness Endpoint : AAA Sac Regression at 1 year
Measured over 1 year
+1 more outcome measured
Conditions
Where it's being run
49 sites across 29 statesNew York6
Florida4
Texas4
Massachusetts3
Virginia3
California2
Michigan2
Ohio2
Study leadership
- Marc Schermerhorn, M.D. · PRINCIPAL_INVESTIGATOR · Beth Israel Deaconess Medical Center
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Primary Effectiveness Endpoint : AAA Sac Regression at 1 year1 year
The percentage of subjects showing regression, defined as sac volume reduction of ≥10% at 1 year (in comparison to the 30 day CT), and no AAA-related intervention through 1 year.
- Primary Safety Endpoint : Major Adverse Event (MAE) Rate through 30 days30 days
Freedom from the following through 30 days post-index procedure: * Major adverse events (MAEs) which include the following: all-cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, procedural blood loss \>1000 mL. * AAA-rupture or AAA-perforation * Conversion to Open Repair