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

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

NCT07020611•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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient can understand the purpose of the trial, voluntarily participate in the trial and sign the informed consent
•Patient is willing to complete the follow-up according to the requirements of the protocol.
•Patient AAA anatomy complies with "instructions for use" for commercial EVAR devices used
•≥18 years old
•Abdominal aortic aneurysm with sac diameter ≥ 5.5cm in males and ≥ 5.0cm in females
•Maximum blood flow luminal diameter ≤ 50mm
•Eligible for endovascular aneurysm repair based on anatomical considerations, such as adequate iliac/femoral access
•Patient is American Society of Anesthesiology (ASA) grade 1 through 3, inclusive.

Exclusion Criteria

•Concomitant Common Iliac Artery aneurysms ≥ 25mm
•Life expectancy \<2 years
•Already participating in an investigational drug or device study
•Known allergy or contraindication to any study device material
•Coagulopathy or uncontrolled bleeding disorder
•Ruptured, leaking, inflammatory or mycotic aneurysm
•Connective tissue diseases (e.g., Marfan Syndrome)
•Unsuitable vascular anatomy that may interfere with device introduction or deployment, in the opinion of the investigator
•Aneurysmal or dissected disease of the descending thoracic aorta
•Previous surgical or EVAR repair for AAA
+7 more criteria

Locations (1)

Auckland City Hospital

Auckland, New Zealand

Key Dates

Start Date

November 26, 2025

Primary Completion Date

September 1, 2026

Completion Date

September 1, 2028

Last Updated

December 9, 2025

Enrollment

ESTIMATED participants

Conditions

Abdominal Aortic Aneurysm

Interventions

Cygnum Aneurysm Sac Management Device (ASMD)

DEVICE

Contacts

Raja N Ghanem

CONTACT

612-840-2723 contact@lifesealvascular.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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