Study of the Cygnum Device to Manage Abdominal Aortic Aneurysms During Endovascular Repair Evaluating Safety and Effectiveness to Prevent Type II Endoleaks

What this Trial Is About

Researchers are evaluating the safety and feasibility of the Cygnum Aneurysm Sac Management Device ASMD in patients with abdominal aortic aneurysms AAA undergoing endovascular aneurysm repair EVAR. The study aims to determine if the Cygnum device is safe when used alongside standard EVAR endografts and if it can reduce or prevent type II endoleaks by managing the aneurysm sac. This first-in-human trial is sponsored by Life Seal Vascular Inc. and focuses on patients with specific aneurysm sizes and anatomy suitable for EVAR. Participants will receive the Cygnum ASMD device implanted during their EVAR procedure. This device lines the aneurysmal wall to help prevent type II endoleaks. The study includes a single treatment arm where all participants undergo EVAR with adjunctive implantation of the Cygnum device. The intervention is performed once, and patients are then followed to monitor outcomes and device performance. Throughout the study, participants will undergo follow-up evaluations including imaging tests such as CT scans and clinical assessments to observe the devices position and aneurysm sac behavior over time. Researchers will measure safety outcomes like major adverse events within 30 days and technical success immediately after the procedure. Longer-term outcomes at 12 months include related adverse events, the presence of type II endoleaks, and changes in aneurysm sac size. Participants will be closely monitored for up to a year to assess these measures.

First-In-Human Study Evaluating Aneurysm Sac Lining in AAA Patients