New device aims to stop aneurysm growth without open surgery
NCT ID NCT05133492
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new device called the Nectero EAST System in 46 people with abdominal aortic aneurysms (AAA). The goal is to see if it is safe and can stop the aneurysm from growing, reducing the need for major surgery. Participants receive the device through a catheter, and doctors monitor their aneurysm size over 36 months.
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
-
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
-
46 people
The number who actually took part.
- Started
-
Jun 2019
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
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
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or Female aged 18 years or older * Subject can understand the purpose of the trial, voluntarily participate in the trial and sign the informed consent and is willing to complete the follow-up according to the requirements of the protocol. * Infrarenal non-aneurysmal neck ≥15mm in length * Aortic neck diameters ≤ 29mm * Infrarenal neck angulation ≤ 60° * Abdominal aneurysm from 3.5 cm to 5.0 cm. * Overall AAA treatment length (distal renal to distal inferior margin of the aneurysm) not to exceed 10 cm * Patient iliac or femoral arteries access vessels' size and morphology allow endovascular access of 14F introducer sheaths and catheters. * Subject has \> one-year life expectancy. * Subject is American Society of Anesthesiology (ASA) grade 1 through 3, inclusive. * Subject is able and willing to comply with 1, 3, 6, 12, 24 and 36-month follow-up. Exclusion Criteria: * Subject has an acutely ruptured or leaking or emergent aneurysm. * Subject has a dissecting aneurysm. * Subject has a mycotic or infected aneurysm. * Subject has current vascular injury due to trauma. * Subject's aneurysm is thoracic or suprarenal. * Previous surgical or endovascular aneurysm repair for abdominal aortic aneurysm. * Subject has thrombus, calcification, and/or plaque that may compromise delivery. * Subject has had a myocardial infarction within six (6) months prior to enrollment. * Subject has current angina or other active cardiac condition such as congestive heart failure, untreated or worsening atrial arrhythmia, ventricular arrhythmia, or valvular disease. * Subject has undergone other major surgery within the 30 days prior to enrollment. * Subjects with any transient ischemic attack (TIA) or ischemic stroke within 3 months. * Known allergy to polyester or contrast material that cannot be pretreated. * Subject is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta. * Subject has connective tissue disease (e.g., Marfan syndrome, Eaton syndrome, or Bessel's disease). * Known contraindication to undergoing angiography or anticoagulation. * Subject has active systemic infection. * Subject is participating in another research study. * Subject has other medical, social, or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment and the procedures and evaluations pre- and post-treatment. * Women of childbearing potential who are pregnant, lactating, or planning to become pregnant during the course of the trial. * Subject has dialysis dependent renal failure or baseline serum creatinine level \>2.0mg/dl. * Subjects with liver dysfunction: alanine transaminase (ALT) or aspartate transaminase (AST) is five times higher than the normal upper limit; serum total bilirubin (STB) is two times higher than the normal upper limit. * Subjects who are not suitable for endovascular treatment, as judged by the investigator.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for AAA are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
Contacts and locations
Locations
-
Auckland City Hospital
Auckland, New Zealand
-
Pablo Tabon Uribe Hospital
Medellín, Antioquia, Colombia
-
Pauls Stradins Clinical University Hospital
Riga, Latvia
-
Prince of Wales Private Hospital
Randwick, New South Wales, 2031, Australia
-
Queen Mary Hospital
Hong Kong, Southern District, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Real-World data collection of the GORE® VIABAHN® VBX balloon expandable endoprosthesis when used as a bridging stent with branched and fenestrated endografts in the treatment of aortic aneurysms involving the Renal-Mesenteric arteries
- Stent graft showdown: which device best tames aortic aneurysms?
- 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?