Nectero EAST System Retreatment Study (NCT07505082) | Clinical Trial Compass
RecruitingNot Applicable
Nectero EAST System Retreatment Study
Australia, New Zealand10 participantsStarted 2026-03-03
Plain-language summary
This is an exploratory pilot study to evaluate the safety and clinical utility of retreatment with an investigational combination product called the Nectero EAST System to treat Abdominal Aortic Aneurysms or AAA.
Who can participate
Age range
21 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Received initial Nectero EAST System treatment under protocol CTP-001.
. Males and females ≥21 to ≤85 years of age. Females must be of non-childbearing potential (menopause or sterilization).
. Subject understands the purpose of the trial, agrees to voluntarily participate in the trial, signs the informed consent and is willing to complete the follow-up according to the requirements of the protocol.
. Infrarenal atherosclerotic fusiform abdominal aortic aneurysm ≤5.3 cm (male) and ≤4.8 cm (female).
. Infrarenal aortic neck ≥ 15 mm in length and ≤ 29 mm in diameter.
. Overall AAA treatment length (distal renal artery to distal inferior margin of the aneurysm) not to exceed 130 mm.
. Iliac and femoral artery access, vessel size and morphology allow endovascular access of 14F (or larger) introducer sheaths and catheters.
. Subject meets American Society of Anesthesiology (ASA) grade 1 through 3 criteria, inclusive.
Exclusion criteria
. Subject has an acutely ruptured, leaking, dissecting or emergent aneurysm.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Subject has a symptomatic infrarenal abdominal aortic aneurysm.
. Subject has a mycotic or infected aneurysm.
. Subject has current vascular injury due to trauma.
. Subject's aneurysm is thoracic, suprarenal or juxtarenal.
. Previous surgical or endovascular aneurysm repair for abdominal aortic aneurysm.
. Subject has anatomy of diffuse, ulcerated, or extensive (shaggy) thrombus in the neck of the AAA, that in the opinion of the vascular surgeon/investigator, could result in embolization of the thrombus.
. Subject has anatomy of calcification, and/or plaque within the ilio-femoral arteries or severe infrarenal neck angulation that may compromise or does not allow delivery of the Introducer Sheath or the delivery catheter of the Nectero EAST System.