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

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

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

Study Overview

• Status: Recruiting
• Conditions: Abdominal Aortic Aneurysm
• Intervention / Treatment: Device: Cygnum Aneurysm Sac Management Device (ASMD)

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raja N Ghanem; Phone Number: 612-840-2723; Email: contact@lifesealvascular.com

Study Locations

• New Zealand
  • Auckland, New Zealand
    • Recruiting
    • Auckland City Hospital
    • Contact: Helen Knight; Phone Number: +64 22 678 0040; Email: helen@veraresearch.nz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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
• Myocardial infarction and/or major heart surgery ≤ 90 days prior to the procedure
• Transient Ischemic Attack or stroke ≤ 90 days prior to the procedure
• Unstable angina or other active cardiac condition such as congestive heart failure, untreated or worsening atrial arrhythmia, ventricular arrhythmia or valvular disease ≤ 30 days prior to the procedure
• Unable or unwilling to comply with study follow-up requirements
• Serum creatinine level ≥ 180 µmol/L
• Patients of childbearing potential who are pregnant or planning to become pregnant during the course of the study
• Patient has other medical, social or psychological problems that, in the opinion of the investigator, study involvement would not be in their best interest.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cygnum ASMD Arm	Device: Cygnum Aneurysm Sac Management Device (ASMD); Cygnum ASMD, adjunctive to EVAR, lines the aneurysmal wall to prevent type II endoleaks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of major adverse events (MAEs)	Rate of related major adverse events (MAEs)	30 days post-procedure
Procedural Technical Success	Technical success, defined as lining the AAA sac wall with the investigational devices	Immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of related major adverse events (MAEs)	Incidence rate of related major adverse events (MAEs)	12 months post procedure
Incidence of related serious adverse events (SAEs)	Incidence rate of related serious adverse events (SAEs)	12 months post procedure
Efficacy - Type II endoleaks	Incidence of type II endoleaks	12 months post procedure
Efficacy - AAA sac diameter	Change in AAA sac diameter	12 months post procedure

Collaborators and Investigators

• Sponsor: Life Seal Vascular Inc.
• Collaborators: Auckland City Hospital
• Investigators: Study Director: Raja Ghanem, Life Seal Vascular Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: May 27, 2025
• First Submitted That Met QC Criteria: June 5, 2025
• First Posted (Actual): June 13, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: CP-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes