First-in-Human Study of Shape Memory Polymer Device for Treating Aortic Dissection False Lumen to Prevent Aortic Growth

What this Trial Is About

Researchers are evaluating the safety and feasibility of a new device called the False Lumen Embolization System IMPEDE-FX RapidFill to reduce blood flow into the false lumen in patients with aortic dissection. This first-in-human study aims to prevent the growth of the aorta by treating the false lumen, which is a common concern in this condition. The sponsor leading this study is Shape Memory Medical, Inc. Participants will receive treatment using the investigational device designed to block the false lumen of the aorta. The study involves a single experimental group where the device will be delivered to the affected area to achieve embolization. The treatment is performed once, and its technical success will be assessed immediately after the procedure. The study does not include placebo or comparison groups. During the study, participants will be closely monitored for technical success right after the intervention and for major adverse events up to 30 days post-treatment. Follow-up evaluations will continue for up to two years to track mortality, serious adverse events, changes in the false lumen and aorta size, and the need for any further interventions. Various imaging and clinical assessments will be used throughout the follow-up period to evaluate the devices impact and participant safety.

False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study