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

Launched by LIFE SEAL VASCULAR INC. · Jun 5, 2025

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ClinConnect Summary

This clinical trial is focused on testing a new device called the Cygnum Aneurysm Sac Management Device in patients with a condition known as abdominal aortic aneurysms (AAA). The goal is to see if this device is safe to use alongside standard treatment called endovascular aneurysm repair (EVAR) and whether it can help reduce or prevent complications known as type II endoleaks, which can occur after surgery.

To participate in the trial, patients need to be at least 18 years old and have a specific size of aneurysm. They should be able to understand the purpose of the study and agree to take part. During the study, participants will undergo the EVAR procedure along with the Cygnum device and will have follow-up check-ups, including imaging tests like CT scans, to monitor their recovery and how the device is working. It's important to know that this trial is not yet recruiting participants, and there are certain health conditions that may prevent someone from joining, like having a life expectancy of less than two years or other serious medical issues.

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Eligibility 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.