- AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion — Recruiting • Non-phase study • Cardiology / Cardiovascular • NCT06029660.
- What is being tested: IMPEDE-FX RapidFill, an adjunctive embolic agent used alongside standard endovascular aneurysm repair (EVAR) stent grafts, to promote AAA sac shrinkage and prevent aneurysm expansion.
- Patient eligibility overview: Adults with abdominal aortic aneurysms suitable for EVAR treatment who meet protocol-specific anatomical and clinical criteria for stent graft placement.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
To determine the safety and effectiveness of IMPEDE-FX RapidFill to increase the percentage of subjects with shrinkage of the abdominal aortic aneurysm sac when used as an adjunct to on-label endovascular aneurysm repair (EVAR) stent graft treatment in trial subjects considered candidates for elective EVAR.
- : 1. ≥18 years of age 2. A candidate for elective EVAR of an infrarenal fusiform aortic aneurysm ≥5.5 cm in diameter in men and ≥5.0 cm in women; 3. Thrombus burden (percentage of the AAA sac occupied by thrombus)
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.