Cygnum aneurysm sac lining used with EVAR for abdominal aortic aneurysm
Aneurysm SaC ManagemENt Device for Abdominal Aortic Aneurysms First-in-Human (ASCEND) Study
This trial will test whether adding the Cygnum sac lining to standard EVAR is safe and helps prevent type II endoleaks in people with abdominal aortic aneurysms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Life Seal Vascular Inc. Industry-sponsored |
| Locations | 1 site (Auckland) |
| Trial ID | NCT07020611 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults eligible for standard EVAR (ASA grade 1–3) with abdominal aortic aneurysms meeting the size thresholds (≥5.5 cm in men, ≥5.0 cm in women) and anatomy compatible with commercial endografts.
Not a fit: Patients with ruptured, leaking, inflammatory, or mycotic aneurysms, large common iliac aneurysms, a life expectancy under two years, clotting disorders, device material allergies, or who cannot undergo follow-up are unlikely to benefit.
Why it matters
Potential benefit: If successful, the device could lower the rate of type II endoleaks and reduce sac growth and need for additional procedures after EVAR.
How similar studies have performed: This is the first human trial of the Cygnum device, though prior strategies targeting the aneurysm sac (such as embolization or sac fillers) have had mixed results.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Auckland
- Auckland City Hospital — Auckland, New Zealand (Recruiting)
Study contacts
- Study coordinator: Raja N Ghanem
- Email: contact@lifesealvascular.com
- Phone: 612-840-2723
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.