Actively Recruiting
First-In-Human Study Evaluating Aneurysm Sac Lining in AAA Patients
Led by Life Seal Vascular Inc. · Updated on 2025-12-09
15
Participants Needed
1
Research Sites
144 weeks
Total Duration
On this page
Sponsors
L
Life Seal Vascular Inc.
Lead Sponsor
A
Auckland City Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
First-In-Human Study Evaluating Aneurysm Sac Lining in AAA Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or older
- Abdominal aortic aneurysm with sac diameter 65 5.5 cm in males and 65 5.0 cm in females
- Maximum blood flow luminal diameter 64 50 mm
- 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 will not qualify if you...
- Concomitant Common Iliac Artery aneurysms 65 25 mm
- Life expectancy less than 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 65 180 �b5mol/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.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Auckland City Hospital
Auckland, New Zealand
Actively Recruiting
Research Team
R
Raja N Ghanem
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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