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5,000 heart patients enrolled in global registry to see if Drug-Coated balloons deliver lasting results

NCT ID NCT07559903

Knowledge-focused Sponsor: Emory University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 registry is following 5,000 adults with coronary artery disease who received a drug-coated balloon during a procedure to open blocked heart arteries. Researchers are tracking how often the treated artery fails, heart attacks, repeat procedures, and bleeding over the long term. The goal is to gather real-world data on the safety and effectiveness of this approach.

What this could mean

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

Active substance
drug-coated balloon
What this could lead to
If successful, this registry could provide real-world evidence on how well drug-coated balloons work for treating coronary artery disease, potentially guiding future treatment guidelines.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by patient selection and other treatments.

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 5,000 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

May 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The participants are patients undergoing standard-of-care DCB PCI for de novo CAD at participating sites. Eligibility will be determined by trained research personnel via a review of the EMR to ensure patients meet the inclusion criteria.

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: * All adult patients (≥ 18 years of age) undergoing PCI for de novo CAD using DCB Exclusion Criteria: * Patients under the age of 18; PCI procedures without the utilization of DCB; PCI procedures for non de novo lesions

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

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

    19 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

  • Allina Health Minneapolis Heart Institute

    NOT_YET_RECRUITING

    Minneapolis, Minnesota, 55407, United States

  • Banner University Medical Center

    NOT_YET_RECRUITING

    Phoenix, Arizona, 85006, United States

  • Brigham and Women's Hospital

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02115, United States

  • Duke University Hospital

    NOT_YET_RECRUITING

    Durham, North Carolina, 27707, United States

  • Emory Johns Creek Hospital

    RECRUITING

    Johns Creek, Georgia, 30097, United States

  • Emory Saint Joseph's Hospital

    RECRUITING

    Atlanta, Georgia, 30342, United States

  • Emory University Hospital

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Emory University Hospital Midtown

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Holy Cross Health Fort Lauderdale

    NOT_YET_RECRUITING

    Fort Lauderdale, Florida, 33308, United States

  • Montefiore Medical Center

    NOT_YET_RECRUITING

    New York, New York, 10467, United States

  • New York-Presbyterian/Weill Cornell Medical Center

    NOT_YET_RECRUITING

    New York, New York, 10065, United States

  • Sanger Heart & Vascular Institute

    NOT_YET_RECRUITING

    Charlotte, North Carolina, 28203, United States

  • St. Francis Hospital & Heart Center

    NOT_YET_RECRUITING

    Roslyn, New York, 11576, United States

  • The Mount Sinai Hospital

    NOT_YET_RECRUITING

    New York, New York, 10029, United States

  • Tufts Medical Center

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02111, United States

  • Universitatsklinikum des Saarlandes

    NOT_YET_RECRUITING

    Homberg (Efze), Germany

  • University Clinical Centre of Serbia

    NOT_YET_RECRUITING

    Belgrade, Serbia

  • University Hospitals Cleveland Medical Center

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44106, United States

  • Vanderbilt University Medical Center

    NOT_YET_RECRUITING

    Nashville, Tennessee, 37232, United States

More trials for these conditions

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