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New balloon treatment for heart disease under study

NCT ID NCT06535854

Disease control Sponsor: Medtronic Vascular 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a special balloon coated with a drug (paclitaxel) to open blocked heart arteries. About 1,200 adults with coronary artery disease will receive either the Prevail balloon or another similar balloon. The goal is to see if the Prevail balloon is safe and works well at keeping arteries open for at least a year.

What this could mean

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

Active substance
paclitaxel-coated balloon catheter
What this could lead to
If successful, this could offer a new treatment option for people with narrowed heart arteries, potentially reducing the need for repeat procedures.
What could go wrong
This is an early-stage study, so results may not confirm long-term benefits. Risks include allergic reactions to the drug or device, and the balloon may not work as well as expected.

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 1,205 people

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

Started

Feb 2025

Expected to finish

Feb 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.

Inclusion Criteria: * ≥ 18 years * Negative pregnancy test * Stable or unstable angina, positive functional test, or stable NSTEMI * Life expectancy \>1 year * Willing and able to cooperate with study procedures and required follow up evaluations Exclusion Criteria: * Known hypersensitivity or contraindication to antiplatelet medications or a sensitivity to contrast media which cannot be adequately pre-medicated * History of an allergic reaction or significant sensitivity to paclitaxel or any other analogue or derivative * Platelet count \< 100,000 cells/mm³ or \> 700,000 cells/mm³, or a white blood cell (WBC) count \< 3,000 cells/mm³ * Renal insufficiency (or failure) * Acute MI * Previous PCI of the target vessel within 6 months prior to the procedure * Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of the target vessel within 12 months post-procedure * History of a stroke or transient ischemic attack (TIA) * Active peptic ulcer or upper gastrointestinal (GI) bleeding * History of bleeding diathesis or coagulopathy or will refuse blood transfusions * Documented left ventricular ejection fraction (LVEF) \<30% * Planned surgery that would cause interruption in recommended DAPT duration per current guidelines * Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires additional coronary angiography, IVUS or other coronary artery imaging procedures

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Conditions

The condition(s) this trial relates to.

coronary artery disorder coronary microvascular disorder coronary restenosis

As listed by the trial registrant

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

Coronary artery disease

How to take part

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

  1. The places running it

    51 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

  • Advocate Illinois Masonic Medical Center

    RECRUITING

    Chicago, Illinois, 60657, United States

  • AnMed Health Medical Center

    RECRUITING

    Anderson, South Carolina, 29621, United States

  • Ascension Via Christi Saint Francis

    RECRUITING

    Wichita, Kansas, 67214, United States

  • BayCare Health System

    RECRUITING

    Clearwater, Florida, 33756, United States

  • Baylor Heart & Vascular Hospital

    RECRUITING

    Dallas, Texas, 75226, United States

  • Carondelet Saint Marys

    RECRUITING

    Tucson, Arizona, 85745, United States

  • CentraCare Heart & Vascular Center MN - Saint Cloud Hospital

    RECRUITING

    Saint Cloud, Minnesota, 56303, United States

  • Corewell Health

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Cumc/Nyph

    RECRUITING

    New York, New York, 10032, United States

  • Emory University Hospital Midtown

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Gundersen Lutheran

    RECRUITING

    La Crosse, Wisconsin, 54601, United States

  • HCA Houston Medical Center

    RECRUITING

    Houston, Texas, 77004, United States

  • Hospital of the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Huntsville Hospital

    RECRUITING

    Huntsville, Alabama, 35801, United States

  • John L McClellan Memorial Veterans Hospital

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • Kaleida Health

    RECRUITING

    Buffalo, New York, 14214, United States

  • Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist)

    RECRUITING

    Overland Park, Kansas, 66211, United States

  • Lehigh Valley Hospital - Cedar Crest

    RECRUITING

    Allentown, Pennsylvania, 18103, United States

  • M Health Fairview Clinic

    RECRUITING

    Edina, Minnesota, 55435, United States

  • Medical Center of the Rockies

    RECRUITING

    Loveland, Colorado, 80538, United States

  • Medical University of South Carolina (MUSC)

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Medstar Washington Hospital Center

    RECRUITING

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

  • Midwest Cardiovascular Institute

    RECRUITING

    Naperville, Illinois, 60540, United States

  • Montefiore Medical Center

    RECRUITING

    New York, New York, 10467, United States

  • North Florida Regional Medical Center

    RECRUITING

    Gainesville, Florida, 32605, United States

  • Novant Health New Hanover Regional Medical Center

    RECRUITING

    Wilmington, North Carolina, 28401, United States

  • OhioHealth Riverside Methodist Hospital

    RECRUITING

    Columbus, Ohio, 43214, United States

  • Oregon Health & Science University Hospital

    RECRUITING

    Portland, Oregon, 97239, United States

  • Parkview Health

    RECRUITING

    Fort Wayne, Indiana, 46845, United States

  • Piedmont Atlanta Hospital

    RECRUITING

    Atlanta, Georgia, 30309, United States

  • Providence Saint Patrick Hospital

    RECRUITING

    Missoula, Montana, 59802, United States

  • Rhode Island Hospital and Health Services - Lifespan

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • Saint Elizabeth Healthcare

    RECRUITING

    Edgewood, Kentucky, 41017, United States

  • Saint Francis Hospital (Roslyn NY)

    RECRUITING

    Roslyn, New York, 11576, United States

  • Saint Joseph Mercy Ann Arbor

    RECRUITING

    Ypsilanti, Michigan, 48197, United States

  • Saint Lukes Mid America Heart Institute

    RECRUITING

    Kansas City, Missouri, 64111, United States

  • Stanford Hospital & Clinics

    RECRUITING

    Stanford, California, 94305, United States

  • The Heart Hospital Baylor Plano

    RECRUITING

    Plano, Texas, 75093, United States

  • The Lindner Research Center

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • The Moses H Cone Memorial Hospital

    RECRUITING

    Greensboro, North Carolina, 27401, United States

  • The University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • The Valley Hospital

    RECRUITING

    Paramus, New Jersey, 07652, United States

  • TriStar Centennial Medical Center

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • UPMC Pinnacle Harrisburg Campus

    RECRUITING

    Harrisburg, Pennsylvania, 17101, United States

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Miami Hospital

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Michigan Health System - University Hospital

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Washington (UW) Medical Center

    RECRUITING

    Seattle, Washington, 98195, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Virtua Our Lady of Lourdes Hospital

    RECRUITING

    Camden, New Jersey, 08103, United States

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