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New device aims to fix dangerous belly aneurysms without major surgery

NCT ID NCT03298477

Disease control Sponsor: Endologix Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a device called the Nellix system to repair a bulging blood vessel (aneurysm) in the belly without open surgery. 98 people with large or growing aneurysms took part. The goal was to see if the device is safe and works well at keeping the aneurysm from bursting or needing more procedures over 2 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

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

98 people

The number who actually took part.

Started

Dec 2017

Finished

Aug 2025

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

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 A patient who meets all of the following criteria potentially may be included in the study: 1. Male or female at least 18 years old; 2. Informed consent form understood and signed 3. Patient agrees to all follow-up visits; 4. Abdominal aortic aneurysm with sac diameter ≥5.0cm, or ≥4.5cm which has increased by ≥0.5cm within the last 6 months, or or which exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment. No AAA \<4 cm will be included. 5. Anatomically eligible for the Nellix System (per Instructions For Use): 1. Adequate iliac/femoral access compatible with the required delivery systems (diameter ≥6 mm); 2. Aneurysm blood lumen diameter ≤60mm; 3. Proximal non-aneurysmal aortic neck: length ≥10mm; diameter 18 to 28mm; angle ≤60° to the aneurysm sac; 4. Most caudal renal artery to each hypogastric artery length ≥100mm; 5. Common iliac artery lumen diameter between 9 and 35mm; 6. Distal iliac artery seal zone with length of ≥10mm and diameter range of 9 to 25mm; 7. Ability to preserve at least one hypogastric artery. 8. Ratio of maximum aortic aneurysm diameter to maximum aortic blood lumen diameter \<1.40 EXCLUSION CRITERIA A patient who meets none of the following criteria potentially may be included in the study: 1. Life expectancy \<2 years as judged by the Investigator; 2. Psychiatric or other condition that may interfere with the study; 3. Participating in another clinical study; 4. Known allergy or contraindication to any device material; 5. Coagulopathy or uncontrolled bleeding disorder; 6. Ruptured, leaking or mycotic aneurysm; 7. Serum creatinine (S-Cr) level \>2.0 mg/dL; 8. CVA or MI within three months of enrollment/treatment; 9. Aneurysmal disease of the descending thoracic aorta; 10. Clinically significant mural thrombus within the proximal landing zone (minimum 10mm) of the infrarenal non-aneurysmal neck (\>5mm thickness over \>50% circumference); 11. Connective tissue diseases (e.g., Marfan Syndrome); 12. Unsuitable vascular anatomy that may interfere with device introduction or deployment; 13. Pregnant (female of childbearing potential only).

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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 without rupture

Contacts and locations

Locations

  • AMITA Health

    Elk Grove Village, Illinois, 60007, United States

  • AdventHealth Orlando

    Orlando, Florida, 32803, United States

  • Aspirus Research Institute

    Wausau, Wisconsin, 54401, United States

  • Cardiovascular Surgery Clinic

    Memphis, Tennessee, 38120, United States

  • Christie Clinic

    Champaign, Illinois, 61820, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Coastal Vascular & Interventional

    Pensacola, Florida, 32503, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Inova Research Center

    Falls Church, Virginia, 22042, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • McLaren Bay Region

    Bay City, Michigan, 48708, United States

  • MedStar Health Research Institute

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

  • Miami Cardiac & Vascular Institute (MCVI)

    Miami, Florida, 33176, United States

  • Midwest Aortic & Vascular Institute

    Kansas City, Missouri, 64116, United States

  • New Mexico Heart Institute

    Albuquerque, New Mexico, 87102, United States

  • Northeast Ohio Vascular Assoc (NEOVA)

    Willoughby, Ohio, 44095, United States

  • OU College of Medicine

    Tulsa, Oklahoma, 74135, United States

  • Palmetto Health- University of South Carolina

    Columbia, South Carolina, 29203, United States

  • Providence Sacred Heart Medical Center

    Spokane, Washington, 99204, United States

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97213, United States

  • Regents of the University of California (UCLA)

    Los Angeles, California, 90095, United States

  • St. Vincent Heart Center of Indiana

    Indianapolis, Indiana, 46290, United States

  • The Cooper Health System

    Camden, New Jersey, 08103, United States

  • UC Health-Memorial Hospital

    Colorado Springs, Colorado, 80909, United States

  • Valley Vascular Consultants

    Huntsville, Alabama, 35801, United States

  • Veterans Medical Research Foundation

    San Diego, California, 92161, United States

  • Wellmont CVA Heart Institute

    Kingsport, Tennessee, 37660, United States

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