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RECRUITING
NCT07020611
NA

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

Sponsor: Life Seal Vascular Inc.

View on ClinicalTrials.gov

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

Interventions

DEVICE

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