Clinical Research Directory
Browse clinical research sites, groups, and studies.
First-In-Human Study Evaluating Aneurysm Sac Lining in AAA Patients
Sponsor: Life Seal Vascular Inc.
Summary
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
Official title: Aneurysm SaC ManagemENt Device for Abdominal Aortic Aneurysms First-in-Human (ASCEND) Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2025-11-26
Completion Date
2028-09
Last Updated
2025-12-09
Healthy Volunteers
No
Conditions
Interventions
Cygnum Aneurysm Sac Management Device (ASMD)
Cygnum ASMD, adjunctive to EVAR, lines the aneurysmal wall to prevent type II endoleaks
Locations (1)
Auckland City Hospital
Auckland, New Zealand