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New device aims to stop aneurysm growth without open surgery

NCT ID NCT05133492

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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.

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.