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New One-Time procedure aims to prevent dangerous aneurysm growth

NCT ID NCT06001918

Disease control Sponsor: Nectero Medical, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 treatment called the Nectero EAST System for people with small to medium abdominal aortic aneurysms (AAA). The goal is to see if a single treatment delivered through a catheter can stabilize the aneurysm and prevent it from growing or rupturing. About 400 participants will be randomly assigned to receive the treatment or standard monitoring. Researchers will track outcomes like aneurysm growth, rupture, or need for surgery over up to 5 years.

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

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Dec 2032

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

21 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. Males and females ≥21 to ≤85 years of age. Females must be of non-childbearing potential (menopause or sterilization). 2. 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. 3. Infrarenal atherosclerotic fusiform abdominal aortic aneurysm from 3.5 cm to 5.0 cm (male) and 3.5 cm to 4.5 cm (female). 4. Infrarenal aortic neck ≥ 15 mm in length and ≤ 29 mm in diameter. 5. Overall AAA treatment length (distal renal to distal inferior margin of the aneurysm) not to exceed 130 mm. 6. Iliac and femoral artery access, vessel size and morphology allow endovascular access of 14F (or larger) introducer sheaths and catheters. 7. Subject meets American Society of Anesthesiology (ASA) grade 1 through 3 criteria, inclusive. 8. Subject has \> three-year life expectancy. 9. Subject is able and willing to comply with all required follow-up clinic visits including CT scans (pre-randomization, 6, 12, 18, 24 months and annually up to 5 years) and blood draws. Exclusion Criteria: 1. Subject has an acutely ruptured, leaking, dissecting or emergent aneurysm. 2. Subject has a symptomatic infrarenal abdominal aortic aneurysm. 3. Subject has a mycotic or infected aneurysm. 4. Subject has current vascular injury due to trauma. 5. Subject's aneurysm is thoracic, suprarenal or juxtarenal. 6. Previous surgical or endovascular aneurysm repair for abdominal aortic aneurysm. 7. 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. 8. 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. 9. Subject has had a myocardial infarction within six (6) months prior to enrollment or elevated CK enzymes or troponin indicative of an evolving MI prior to procedure. 10. Subject has current angina, unstable angina, or other active cardiac condition such as congestive heart failure III and IV, atrial arrhythmia, ventricular arrhythmia, or valvular disease, requiring intervention. 11. Subject has undergone other major surgery within the 30 days prior to enrollment. 12. Subjects with any transient ischemic attack (TIA) or ischemic stroke within 3 months. 13. Known allergy to contrast material that cannot be adequately premedicated, delivery system materials (i.e., nylon, polyurethane) and/or pentagalloylglucose (PGG). 14. Subject is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta. 15. Subject has connective tissue/collagen disorder (e.g., Marfan syndrome, vascular Ehlers-Danlos Syndrome, Loeys-Dietz Syndrome, Eaton Syndrome, Bessel-Hagen disease, etc.). 16. Known contraindication to undergoing angiography or receiving systemic anticoagulation during the procedure. 17. Subject has active systemic infection. 18. Subject is participating in another research trial that could interfere with the results of the trial (e.g., drug trial). 19. Subject has other medical, social, or psychological problems that, in the opinion of the investigator, preclude them from participation in the trial and to undergo the procedures and evaluations pre- and post-treatment. 20. Subject has dialysis dependent renal failure or baseline serum creatinine level \>2.5mg/dL or eGFR \< 45 mL/min/1.73m2. 21. Subjects with aminotransferase (ALT and/or AST) which is ≥1.5x upper limit of normal (ULN) or TB that is our of normal range for the evaluating laboratory. 22. Subjects that may not tolerate the lowering of their systolic blood pressure to approximately 100mmHg, should not be considered for this study or treated using the Nectero EAST System. 23. Subjects that may not be able to tolerate transient occlusion of the aorta should not be considered for this study. 24. Subjects with saccular AAA. 25. Subjects with rapidly expanding AAA (previous diameter increases of ≥0.5 cm in 6-months or ≥1 cm in 1 year) as these should be evaluated for immediate repair. 26. Subjects who are not suitable for the Nectero EAST System treatment, as determined by the investigator. 27. Subjects with INR out of normal range for the evaluating laboratory for a subject not on anti-coagulant therapy; or INR \>3 for a subject on anti-coagulant therapy. 28. Subjects with active/acute or a history of unstable chronic liver disease or current liver disease including but not limited to liver transplant, known genetic disorders such as Gilbert syndrome or other liver diseases. 29. Subjects with cirrhosis (e.g., known history or new clinical diagnosis by elastography with a fibrosis score of F3 or F4 and/or steatosis grade of S3). 30. Subjects with uncontrolled alcohol use disorder or current alcohol use putting them at risk of liver disease: including consumption of above one standard drink per day for women and two standard drinks per day for men. 31. Subjects with known right-sided heart failure or pathologically dilated inferior vena cava or hepatic veins indicative of congestive hepatopathy.

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Conditions

The condition(s) this trial relates to.

abdominal aortic aneurysm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Abdominal aortic aneurysm

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    35 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

Locations

  • Auckland City Hospital

    RECRUITING

    Auckland, 1023, New Zealand

  • Baylor Scott & White Medical Center

    RECRUITING

    Plano, Texas, 75093, United States

  • Beaumont Health

    RECRUITING

    Royal Oak, Michigan, 48073, United States

  • Bellin Memorial Hospital

    RECRUITING

    Green Bay, Wisconsin, 54301, United States

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Cleveland Clinic

    ACTIVE_NOT_RECRUITING

    Cleveland, Ohio, 44195, United States

  • Dartmouth Hitchcock Medical Center

    ACTIVE_NOT_RECRUITING

    Lebanon, New Hampshire, 03766, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Honor Health Scottsdale Shea Medical Center

    RECRUITING

    Scottsdale, Arizona, 85258, United States

  • Hospital of the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Houston Healthcare

    RECRUITING

    Houston, Texas, 77004, United States

  • Inova Fairfax Medical Campus Inova Health Systems

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Jefferson Clinical Research Institute

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • MaineMed Vascular Surgery

    NOT_YET_RECRUITING

    Scarborough, Maine, 04074, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Medical College of Georgia

    RECRUITING

    Augusta, Georgia, 30912, United States

  • Medstar Washington Hospital Center

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • North Central Heart - A Division of Avera Heart Hospital

    RECRUITING

    Sioux Falls, South Dakota, 57108, United States

  • Ohio Health Riverside

    RECRUITING

    Columbus, Ohio, 43214, United States

  • Oklahoma Heart Institute

    RECRUITING

    Tulsa, Oklahoma, 74104, United States

  • Portland VA Medical Center

    RECRUITING

    Portland, Oregon, 97239, United States

  • Prime Vascular Institute

    ACTIVE_NOT_RECRUITING

    Delray Beach, Florida, 33446, United States

  • Prince of Wales Private Hospital- POW Vascular Institute

    RECRUITING

    Randwick, New South Wales, 2031, Australia

  • Prisma Health

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • St. Luke's University Health Network

    RECRUITING

    Bethlehem, Pennsylvania, 18015, United States

  • Stony Brook Medicine

    NOT_YET_RECRUITING

    Stony Brook, New York, 11794, United States

  • The Christ Hospital

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • The Ohio State University Wexner Medical Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • University Hospitals Cleveland

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Colorado

    ACTIVE_NOT_RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Massachusetts

    RECRUITING

    Worcester, Massachusetts, 01655, United States

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198, United States

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15219, United States

  • University of Rochester

    RECRUITING

    Rochester, New York, 14642, United States

  • University of Utah Hospital

    RECRUITING

    Salt Lake City, Utah, 84132, United States

  • University of Washington at Harborview Medical Center

    RECRUITING

    Seattle, Washington, 98104, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

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