A Smart Approach:
Post-EVAR aneurysm failure to regress remains a significant unmet clinical need associated with higher long-term all-cause mortality.
AAA-SHAPE is the first prospective clinical trial to evaluate IMPEDE-FX RapidFill in AAA patients and its potential to remodel the AAA sac and improve aneurysm sac regression following EVAR. The study has enrolled 35 patients across three centers in the Netherlands, and two centers in New Zealand.
One year follow-up will be completed in 2023.
Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks (AAA-SHAPE)
AAA-SHAPE is a prospective, multicenter trial to determine the safety and efficacy of the IMPEDE-FX Embolization Plug and/or IMPEDE-FX RapidFill to fill an abdominal aortic aneurysm (AAA) sac outside of an endovascular aneurysm repair (EVAR) stent graft.