Tiny liner could stop aneurysm leaks after surgery
NCT ID NCT07020611
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early study tests a new device called the Cygnum ASMD, which is placed inside the aneurysm during standard repair surgery. The goal is to see if it is safe and can prevent type II endoleaks—small leaks that can cause the aneurysm to grow again. Fifteen adults with large abdominal aortic aneurysms will be enrolled and followed with scans and checkups.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cygnum Aneurysm Sac Management Device (ASMD)
- What this could lead to
- If it works, this device could reduce the need for follow-up procedures after aneurysm repair by preventing internal leaks.
- What could go wrong
- This is a very early, small trial (15 people) testing safety and feasibility only. The device may not work as hoped, and there are risks from the implant procedure itself.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Auckland City Hospital
RECRUITINGAuckland, New Zealand
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Stent graft tested for keeping kidney and gut arteries open during aneurysm repair
- Can sound waves replace CT scans for aortic aneurysm monitoring?
- Can a stent-graft keep aortic aneurysms in check for years? a long-term follow-up study aims to find out.
- Aneurysm repair may stiffen arteries — a study asks what that means for the heart
- Rehab after aneurysm surgery: could a 3-Week program boost heart and lung fitness?
- Nerve block may offer safer pain relief after major aortic surgery