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

NCT07020611 | Recruiting FDA Device

• 1 other identifier: CP-0001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 1.Is the Cygnum device safe when used adjunctively with standard EVAR endografts?
2. 2.Does it effectively reduce or prevent type II endoleaks by managing the aneurysm sac?
3. 3.Undergo EVAR with adjunctive implantation of the Cygnum device
4. 4.Have follow-up imaging (e.g., CT scans) and clinical assessments to evaluate device position and sac behavior over time

Conditions

Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Incidence of related major adverse events (MAEs)

  12 months post procedure

• Incidence of related serious adverse events (SAEs)

  12 months post procedure

• Efficacy - Type II endoleaks

  12 months post procedure

• Efficacy - AAA sac diameter

  12 months post procedure

Study Arms (1)

Cygnum ASMD Arm

EXPERIMENTAL

Device: Cygnum Aneurysm Sac Management Device (ASMD)

Interventions

Cygnum Aneurysm Sac Management Device (ASMD) DEVICE

Cygnum ASMD, adjunctive to EVAR, lines the aneurysmal wall to prevent type II endoleaks

Cygnum ASMD Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Life Seal Vascular Inc.: lead
• Auckland City Hospital: collaborator

Study Sites (1)

Auckland City Hospital

Auckland, New Zealand

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Raja Ghanem

  Life Seal Vascular Inc.

  STUDY DIRECTOR

Central Study Contacts

Raja N Ghanem

CONTACT

612-840-2723; contact@lifesealvascular.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 13, 2025
• Study Start: November 26, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2028
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)