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Breakthrough stent aims to fix Hard-to-Treat aortic aneurysms

NCT ID NCT04875429

Disease control Sponsor: Cook Research Incorporated 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 2 times

Summary

This study tests a new device called the Zenith Fenestrated+ Endovascular Graft, used with special stents, to repair aortic aneurysms that involve arteries to the kidneys and other organs. About 105 people with large or fast-growing aneurysms will be enrolled. The goal is to see if the device can be safely placed and prevent serious problems like rupture or kidney failure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Zenith Fenestrated+ Endovascular Graft with BeGraft stent system
What this could lead to
If successful, this could offer a less invasive treatment option for complex aortic aneurysms that are hard to treat with standard surgery.
What could go wrong
This is an early-stage study with only 105 participants, so results may not apply to everyone. Risks include serious complications like kidney failure, stroke, or bowel injury.

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

About 105 people

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

Started

Dec 2023

Expected to finish

Nov 2031

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

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.

Include Criteria: 1. Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a diameter ≥ 55 mm for males and ≥ 50 mm for females 2. Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a growth rate of ≥ 5 mm in 6 months 3. Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with aortic diameter \> 2x the normal aortic diameter or saccular aneurysm that warrants treatment in the opinion of the investigator Exclusion Criteria: 1. Age \< 18 years 2. Life expectancy \< 2 years 3. Pregnant, breast-feeding, or planning to become pregnant within 60 months 4. Inability or refusal to give informed consent by the patient or legally authorized representative 5. Unwilling or unable to comply with the follow-up schedule, required clinical assessments, and imaging 6. Simultaneous participation in another investigation study, unless the patient is at least 30 days beyond the primary endpoint of any previous study

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Conditions

The condition(s) this trial relates to.

abdominal aortic aneurysm aortic aneurysm cardiovascular disorder vascular disorder

As listed by the trial registrant

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

Aortic aneurysm, abdominal Extent iv thoracoabdominal Juxtarenal aortic aneurysm Pararenal aneurysm

How to take part

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

  1. The places running it

    30 sites. 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

  • Barnes Jewish Hospital

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Carilion Roanoke Memorial Hospital

    ACTIVE_NOT_RECRUITING

    Roanoke, Virginia, 24014, United States

  • Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Columbia University Irving Medical Center/NY Presbyterian Hospital

    RECRUITING

    New York, New York, 10032, United States

  • Dartmouth-Hitchcock Medical Center

    RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • Edward Hospital

    RECRUITING

    Naperville, Illinois, 60540, United States

  • Emory University Hospital

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Endeavor Health Cardiovascular Institute at Glenbrook Hospital

    RECRUITING

    Glenview, Illinois, 60026, United States

  • Holston Valley Hospital

    RECRUITING

    Kingsport, Tennessee, 37660, United States

  • Hospital of the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Loyola University Medical Center

    RECRUITING

    Maywood, Illinois, 60153, United States

  • Massachusetts General Hospital

    COMPLETED

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Medstar Washington Hospital Center

    RECRUITING

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

  • Memorial Hermann Texas Medical Center/UT Health

    RECRUITING

    Houston, Texas, 77030, United States

  • Methodist Hospital of Indiana

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • New York University Langone Medical Center

    RECRUITING

    New York, New York, 10016, United States

  • Northwestern Memorial Hospital

    RECRUITING

    Chicago, Illinois, 60611, United States

  • St Thomas' Hospital

    ACTIVE_NOT_RECRUITING

    London, SE1 7EH, United Kingdom

  • Stanford Hospitals and Clinics

    RECRUITING

    Stanford, California, 94305, United States

  • Tampa General Hospital

    RECRUITING

    Tampa, Florida, 33606, United States

  • UC San Diego

    RECRUITING

    La Jolla, California, 92037, United States

  • University of Alabama Birmingham Hospital

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • University of Florida Shands Hospital

    RECRUITING

    Gainesville, Florida, 32610, United States

  • University of Maryland

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Massachusetts

    RECRUITING

    Worcester, Massachusetts, 01655, United States

  • University of Michigan Health System

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Southern California

    RECRUITING

    Los Angeles, California, 90031, United States

  • Ut Southwestern

    RECRUITING

    Dallas, Texas, 75235, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.