Shape Memory Medical today announced the first European enrolment in the AAA-SHAPE pivotal trial, the company’s prospective, multicentre, randomised, open-label trial to determine the safety and effectiveness of the Impede-FX RapidFill device to improve abdominal aortic aneurysm (AAA) sac behavior when used with elective endovascular aneurysm repair (EVAR). The patient was treated by Jan Heyligers and Patrick Vriens at Elisabeth TweeSteden Hospital in Tilburg, The Netherlands.
“We congratulate Dr Heyligers, Professor Vriens, and the clinical study team at Elisabeth TweeSteden Hospital for being the first centre in Europe to enrol in the AAA-SHAPE pivotal trial,” said Marc Schermerhorn (Beth Israel Deaconess Medical Center, Boston, USA), AAA-SHAPE national principal investigator. “This milestone reflects the unwavering dedication of the physician investigators to advance embolisation solutions and enhance patient care worldwide.”
A press release details that AAA-SHAPE (Abdominal aortic aneurysm sac healing and prevention of expansion) will enrol 180 patients with infrarenal AAA across up to 50 sites in the USA, Europe, and New Zealand. Key endpoints will compare sac diameter and volume change, endoleak rates, and secondary interventions.
“We are proud to be the first site in Europe to treat a patient in this groundbreaking trial,” said Heyligers. “Research shows that 60% of aneurysms either fail to regress or expand within a year after EVAR, often leading to rehospitalisations, additional interventions, and higher mortality rates. The results of this study will be essential in determining whether the Impede-FX RapidFill, with its unique properties, can significantly enhance post-EVAR AAA outcomes and elevate the standard of patient care,” continued Heyligers.
Impede-FX RapidFill, the investigational device, 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.
The AAA-SHAPE pivotal trial builds upon the AAA-SHAPE early feasibility study which enrolled 35 patients in New Zealand and The Netherlands to assess the use of Impede-FX RapidFill for AAA sac embolisation during EVAR.
