Shape Memory Medical Marks 50% Enrollment in AAA-SHAPE Pivotal Trial

October 16, 2025—Shape Memory Medical Inc. announced that it has reached 50% enrollment in the ongoing AAA-SHAPE Pivotal Trial (NCT06029660) evaluating the IMPEDE-FX RapidFill device (Shape Memory Medical) for abdominal aortic aneurysm (AAA) sac management during endovascular aneurysm repair (EVAR), according to the company’s press release.

The prospective, multicenter, randomized, open-label trial is designed to assess the safety and effectiveness of IMPEDE-FX RapidFill in improving aneurysm sac behavior when used adjunctively with elective EVAR. With 90 of 180 patients now enrolled, the study continues to evaluate the potential of sac management to reduce endoleaks and promote sac regression after repair. The latest patient was treated by Aleem Mirza, MD, Principal Investigator and vascular surgeon at Orlando Health Heart and Vascular Institute in Orlando, Florida.

“We are proud to have treated the 90th patient within the AAA-SHAPE Pivotal Trial and to contribute to this important clinical milestone,” Dr. Mirza commented. “The IMPEDE-FX RapidFill’s unique properties may offer meaningful advantages in improving post-EVAR outcomes.”

AAA-SHAPE—Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion—aims to enroll 180 patients with infrarenal AAAs across up to 50 sites in the United States, Europe, and New Zealand. Participants are randomized 2:1 to receive either EVAR with IMPEDE-FX RapidFill or standard EVAR alone. Primary endpoints include changes in sac diameter and volume, endoleak rates, and need for secondary interventions.

The investigational IMPEDE-FX RapidFill device uses the company’s proprietary shape memory polymer, a porous, radiolucent embolic scaffold designed to expand upon blood contact to fill the aneurysm lumen surrounding the stent graft and encourage thrombosis and sac shrinkage.

Prior feasibility studies of AAA-SHAPE enrolled 35 patients in New Zealand and the Netherlands. Three-year follow-up results from these studies are expected to be presented at the upcoming VEITHsymposium in November.

“Published data show that approximately 60% of abdominal aortic aneurysms fail to regress—or even expand—within the first year following EVAR, which has been associated with increased rates of reintervention, rehospitalization, and mortality,” said Virendra Patel, MD, MPH, Global Co-Principal Investigator and Chief of Vascular Surgery and Endovascular Interventions at New York Presbyterian/Columbia University Irving Medical Center. “By promoting sac regression, we have the possibility to significantly improve long-term outcomes for patients undergoing AAA repair.”