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

The goal of this clinical trial is to evaluate the safety and feasibility of the Cygnum Aneurysm Sac Management Device in patients with abdominal aortic aneurysms treated with endovascular aneurysm repair (EVAR). The main questions it aims to answer are: 1. Is the Cygnum device safe when used adjunctively with standard EVAR endografts? 2. Does it effectively reduce or prevent type II endoleaks by managing the aneurysm sac? Participants will: 1. Undergo EVAR with adjunctive implantation of the Cygnum device 2. Have follow-up imaging (e.g., CT scans) and clinical assessments to evaluate device position and sac behavior over time

NCT Number	NCT07020611
Lead Sponsor	Life Seal Vascular Inc. Collaborators: Auckland City Hospital
Conditions	Abdominal Aortic Aneurysm
Enrollment	15 participants
Start Date	2025-11-26
Primary Completion	2026-09 (estimated)
Study Completion	2028-09 (estimated)
Updated on ClinicalTrials.gov	2025-12-09