Shape Memory Medical has reached 50 per cent enrolment in its ongoing AAA-SHAPE pivotal trial, the company announced this week.
AAA-SHAPE is a prospective, multicentre, randomised, open-label trial to determine safety and effectiveness of the Impede-FX RapidFill device to improve abdominal aortic aneurysm (AAA) sac behaviour when used in conjunction with elective endovascular aneurysm repair (EVAR).
The patient was treated by principal investigator Aleem Mirza (Orlando Health Heart and Vascular Institute, Orlando, USA). “We congratulate Dr Mirza and the entire clinical study team at Orlando Health for enrolling the 90th patient in the AAA-SHAPE pivotal trial. AAA-SHAPE is the first randomised controlled trial comparing EVAR plus sac management with Impede-FX RapidFill to standard EVAR alone. The results will be critical in evaluating the potential of Impede-FX RapidFill to promote sac regression and improve outcomes for AAA patients,” said Ted Ruppel, president and chief executive officer of Shape Memory Medical.
AAA-SHAPE will enrol 180 patients with infrarenal AAAs across up to 50 sites in the USA, Europe, and New Zealand. Study participants will be randomised 2:1, either to EVAR plus sac management with Impede-FX RapidFill (the treatment arm) or to standard EVAR (the control arm). Key endpoints will compare sac diameter and volume change, endoleak rates, and secondary interventions.
The investigational device, Impede-FX RapidFill, incorporates Shape Memory Medical’s novel shape memory polymer, a proprietary, porous, radiolucent, embolic scaffold that is crimped for catheter delivery and self-expands upon 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.
Prior to the AAA-SHAPE pivotal trial, the AAA-SHAPE early feasibility studies enrolled a total of 35 patients across sites in New Zealand and the Netherlands. Three-year follow-up data from these studies are scheduled to be presented at the upcoming VEITHsymposium (18–22 November, New York, USA).
“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, rehospitalisation, and mortality. By promoting sac regression, we have the possibility to significantly improve long-term outcomes for patients undergoing AAA repair,” explained co-principal investigator Virendra Patel (New York Presbyterian/Columbia University Irving Medical Center, New York, USA). “We appreciate all the centres who are actively recruiting patients to participate in this important trial. We are highly anticipating the completion of the trial which we believe will provide valuable answers about the potentially important role of sac management in endovascular abdominal aneurysm repair.”
“We are proud to have treated the 90th patient within the AAA-SHAPE pivotal trial and to contribute to this important clinical milestone,” commented Mirza. “The Impede-FX RapidFill’s unique properties may offer meaningful advantages in improving post-EVAR outcomes, and we look forward to the insights this study will provide.”
