NCT07020611

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

Aneurysm SaC ManagemENt Device for Abdominal Aortic Aneurysms First-in-Human (ASCEND) Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Life Seal Vascular Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Abdominal Aortic Aneurysm

Interventions

Type	Name	Description
DEVICE	Cygnum Aneurysm Sac Management Device (ASMD)	Cygnum ASMD, adjunctive to EVAR, lines the aneurysmal wall to prevent type II endoleaks

Timeline

• Start date: 2025-11-26
• Primary completion: 2026-09-01
• Completion: 2028-09-01
• First posted: 2025-06-13
• Last updated: 2025-12-09

Locations

1 site across 1 country: New Zealand

Regulatory

• FDA-regulated device study