Shape Memory Medical’s AAA-SHAPE Pivotal Trial Commences

June 3, 2024—Shape Memory Medical Inc. announced that the first patient was treated in the AAA-SHAPE pivotal trial.

According to the company, the prospective, multicenter, randomized, open-label trial aims to determine the safety and effectiveness of the company’s Impede-FX RapidFill device for improving abdominal aortic aneurysm (AAA) sac behavior when used with elective endovascular aneurysm repair (EVAR). In September 2023, the company announced that the FDA granted an investigational device exemption for Impede-FX RapidFill.

Impede-FX RapidFill incorporates the company’s shape memory polymer, a porous, radiolucent, embolic scaffold that is crimped for catheter delivery and self expands on contact with blood. In AAA-SHAPE, Impede-FX RapidFill is intended to fill the aneurysm blood lumen around a commercially available EVAR stent graft to promote aneurysm thrombosis and sac shrinkage.

The company advised that the trial will enroll 180 patients with infrarenal AAAs at up to 50 sites in the United States, Europe, and New Zealand. Study participants will be randomized 2:1 to the treatment arm of EVAR plus sac management with Impede-FX RapidFill or to the control arm of standard EVAR. Key endpoints will compare sac diameter and volume change, endoleak rates, and secondary interventions.

AAA-SHAPE is led by National Principal Investigator Marc Schermerhorn, MD, Chief of Vascular Surgery at Beth Israel Deaconess Medical Center in Boston, Massachusetts.

The first patient enrolled in the trial was treated by Raghu Motaganahalli, MD, Division Chief of Vascular Surgery and Program Director of the vascular surgery training programs at Indiana University School of Medicine in Indianapolis, Indiana.

“We are pleased to be the first site to treat a patient within the AAA-SHAPE pivotal trial,” commented Dr. Motaganahalli in the company’s press release. “The outcomes of this important trial will help determine whether Impede-FX RapidFill, with its unique properties, plays a meaningful role in post-EVAR AAA outcomes.”

Dr. Schermerhorn added, “Large studies report that 60% of aneurysms either fail to regress or expand within 1 year following EVAR, a problem linked to rehospitalizations, secondary interventions, and increased mortality. Moving more patients toward sac regression has the potential for significant benefits.”

Previously, the AAA-SHAPE early feasibility studies (EFS) enrolled a combined 35 patients in New Zealand and the Netherlands. In June 2023, the EFS experience was described by Andrew Holden, MBChB, et al in Journal of Vascular Surgery: Cases, Innovations, and Techniques.