Aortic Clinical Studies
Investigational device, limited by Federal (or United States) law to investigational use.
The aorta, your largest artery, is the main pathway which carries blood from your heart to the rest of your body. Various disorders and conditions that affect the aorta are classified as aortic diseases.
Aortic Aneurysms are a weakened area in the wall of the aorta, where enlargement or swelling is observed. If left untreated, the weakened aortic wall can balloon and potentially rupture.
Aortic dissection is also a serious condition in which there is a separation between the inner and middle layers of the aorta. When blood flows through that separation (dissection), a new flow channel is created, also referred to as a “false lumen”. This can be a life-threatening situation.
Aortic aneurysms and aortic dissections can be treated through open surgical repair, or through endovascular (less invasive), life-saving procedures called EVAR (Endovascular Aneurysm Repair) or TEVAR (Thoracic Endovascular Aortic Repair).
However, not all aneurysms respond to EVAR, failing to shrink in spite of treatment. Furthermore, TEVAR alone for aortic dissection does not always address the abnormal false lumen flow. These unmet clinical needs are significant and are associated with higher risk of complications, rehospitalization, increased costs, and increased mortality.
Shape Memory Medical is dedicated to patients and physicians by developing new aortic restorative therapies using our novel smart polymer technology through various clinical studies.
AAA-SHAPE Pivotal Trial
The AAA-SHAPE Pivotal Trial is a prospective, multicenter, randomized, open-label trial to determine safety and effectiveness of the IMPEDE-FX RapidFill Device to improve abdominal aortic aneurysm (AAA) sac behavior with used with elective endovascular aneurysm repair (EVAR).
The trial will enroll 180 patients with infrarenal AAA across 50 sites in the U.S., Europe, and New Zealand. Study participants will be randomized 2:1; either to EVAR plus sac management with the IMPEDE-FX RapidFill (the treatment arm) or to standard EVAR (the control arm). Key endpoints will compare sac diameter and volume change, endoleak rates, secondary interventions, and mortality through five years.
Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion (AAA-SHAPE)
The AAA-SHAPE Pivotal Trial is intended 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.
AAA-SHAPE Safety & Early Feasibility Studies
AAA-SHAPE FIH 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 was completed in 2023.
Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks (AAA-SHAPE)
AAA-SHAPE NZ and NLD are prospective, multicenter safety and early feasibility trials 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.
FLAGSHIP First in Human Study
FLAGSHIP FIH is the first prospective clinical trial to evaluate the Smart False Lumen Device in Aortic Dissection patients and its potential to remodel the flow and occlude the tear using various approaches. The study will enroll up to 30 patients across two centers in New Zealand.
False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer – First-in-Human Study.
FLAGSHIP is a prospective multicenter, safety and early feasibility trial to determine the safety and efficacy of the False Lumen Device to prevent aortic growth.
