Cygnum aneurysm sac lining used with EVAR for abdominal aortic aneurysm

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human interventional trial implants the Cygnum Aneurysm Sac Management Device adjunctively during standard endovascular aneurysm repair (EVAR). Participants undergo EVAR with the Cygnum device placed into the aneurysm sac and then return for scheduled imaging (for example CT scans) and clinical assessments to monitor device position, sac size, and endoleaks over time. Primary outcomes focus on safety and device feasibility, with secondary observations on type II endoleak rates and sac behavior. The study enrolls adults with suitable anatomy for commercial EVAR devices and follows ASA grade 1–3 patients for defined follow-up visits.

Why it matters

Who can join: the full rules

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.

Where it's running

• Auckland City Hospital
  Auckland, New Zealand Recruiting

Study contacts

• Study coordinator: Raja N Ghanem
• Email: contact@lifesealvascular.com
• Phone: 612-840-2723

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• CTA registry for abdominal aortic aneurysm measurements

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• Evaluation of a 3D-Printed Stent-Graft for Aortic Aneurysms

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  Recruiting Samodzielny Publiczny Szpital Kliniczny nr 2 PUM · Szczecin, West Pomeranian Voivodeship · NCT06969729

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.