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Mini stent offers hope for babies with blocked heart arteries

NCT ID NCT06828770

Disease control Sponsor: Renata Medical 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is for babies, infants, and small children who have narrowed arteries in or near the heart. Doctors will use a special tiny stent to open the blockage and improve blood flow. The goal is to see how well the stent works and to track any side effects in everyday medical practice. About 100 children will take part across multiple hospitals in the United States.

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.

Participants

About 100 people

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

Started

May 2025

Expected to finish

Dec 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.

Who is studied

Patients treated with the Renata Minima Stent System in the United States

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * The subject's legally authorized representative has been informed of the nature of the device treatment, agrees to its provisions, and has provided written informed consent * Indicated for treatment with the Minima Stent System per the IFU. Exclusion Criteria: * Active bloodstream infection requiring antibiotic therapy within 3 days prior to stent implantation * History of or active endocarditis (active treatment with antibiotics) within 180 days prior to stent implantation * Aortic or pulmonary artery aneurysm in the location targeted for treatment * Body weight \< 1.5 kg * Anatomic location of lesion judged by the investigator to not lend to the safe placement of a stent * Target vessels larger or smaller than the Minima System balloon size ranges * Known genetic syndrome known to be associated with vasculopathies such as but not limited to Williams syndrome, Loeys-Dietz syndrome, etc * Clinical scenario requiring that more than one vessel needs stent implantation at the time of the trial procedure. * Currently participating in an investigational drug study or another device study * Major or progressive non-cardiac disease resulting in a life expectancy of less than six months * Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications * Known hypersensitivity to cobalt-chromium or contrast media that cannot be adequately premedicated

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Conditions

The condition(s) this trial relates to.

aorta coarctation pulmonary branch stenosis pulmonary valve stenosis Stenosis, Pulmonary Artery

As listed by the trial registrant

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

Aortic coarctation Pulmonary artery stenosis

How to take part

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

  1. The places running it

    15 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

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Boston Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Children's Healthcare of Atlanta

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Children's Hospital Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Children's Hospital Los Angeles

    RECRUITING

    Los Angeles, California, 90027, United States

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Columbia Hospital at Medical City Dallas Hospital

    RECRUITING

    Dallas, Texas, 75230, United States

  • Dell Children's Medical Center, The University of Texas at Austin

    RECRUITING

    Austin, Texas, 78723, United States

  • Nationwide Children's Hospital

    RECRUITING

    Columbus, Ohio, 43205, United States

  • Nicklaus Children's Hospital

    RECRUITING

    Miami, Florida, 33155, United States

  • Riley Hospital for Children at Indiana University Health

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Seattle Children's Hospital

    RECRUITING

    Seattle, Washington, 98105, United States

  • UPMC Children's Hospital of Pittsburgh

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • UVA Health Children's Hospital

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • Washington University

    RECRUITING

    Saint Louis, Michigan, 63130, United States

More trials for these conditions

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