Shape Memory Medical has secured investigational device exemption (IDE) approval from the US Food and Drug Administration to begin the clinical trial of the IMPEDE-FX RapidFill device.
The IMPEDE-FX RapidFill investigational device features a new shape memory polymer, a specialised, porous polyurethane scaffold that is crimped for catheter delivery and self-expands when it comes in contact with blood.
The head-to-head Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion (AAA-SHAPE) trial will evaluate the safety and effectiveness of the device in enhancing AAA sac behaviour when used with elective endovascular aneurysm repair (EVAR).
In the trial, the device aims to fill the aneurysm blood lumen surrounding a commercially available EVAR stent graft, promoting the formation of blood clots within the aneurysm and reducing the size of the sac.
It will enrol 180 patients with infrarenal AAA across 40 sites in Europe, New Zealand and the US.
The participants in the study will be randomised into a 2:1 ratio, with one group receiving EVAR plus sac management using IMPEDE-FX RapidFill (the treatment group) and the other group receiving standard EVAR (the control group).
Crucial endpoints will compare sac diameter and volume change, endoleak rates, secondary interventions and mortality through five years.
Shape Memory Medical president and CEO Ted Ruppel said: “Large studies report that 60% of aneurysms fail to regress or expand within one year following EVAR, a problem linked to rehospitalisations, secondary interventions and increased mortality.
“AAA-SHAPE will directly compare EVAR plus sac management with IMPEDE-FX RapidFill to stand-alone EVAR to determine whether shape memory polymer improves patient outcomes post-EVAR.”