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Balloon vs. stent: new hope for tiny heart arteries?

NCT ID NCT06271590

Disease control Sponsor: Concept Medical Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This trial tests a special balloon coated with sirolimus (a drug) to treat small arteries in the heart, compared to standard drug-eluting stents. About 1605 people with coronary artery disease will be randomly assigned to one of the two treatments. The goal is to see if the balloon is as safe and effective as stents for keeping these small vessels open.

What this could mean

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

Active substance
Sirolimus-coated balloon (MagicTouch)
What this could lead to
If successful, this could offer a stent-free option for treating small heart arteries, potentially reducing long-term complications.
What could go wrong
This is a large trial but still early for this device in small vessels. It may not prove superior or even non-inferior to stents, and risks like vessel injury or need for repeat procedures remain.

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 1,605 people

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

Started

May 2025

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 to 80 years

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.

Clinical Inclusion Criteria: 1. Adult patient with an indication for PCI due to stable angina, NSTEACS, post-infarction angina or silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, FFR ≤0.80, or non-hyperemic pressure ratio \[NHPR\] ≤0.89 must be present) 2. Subject is ≥18 and \<80 years old 3. Subject is willing to comply with all protocol-required follow-up evaluations and provides written informed consent Angiographic Inclusion Criteria: 4. Target reference vessel diameter (visual estimation) ≤2.75 mm 5. Successful lesion preparation (residual stenosis \<30%), without flow-limiting complications (no or slow flow, dissection etc.) 6. Target lesion(s) in a native coronary artery 7. Up to two small vessel target lesions in two different vessels 8. Target lesion length (visual estimation): ≥6.0 and ≤34.0 mm and can be covered by a single 40 mm balloon 9. Target lesion diameter stenosis (visual estimation) \>30% and \<100% with Thrombolysis in Myocardial Infarction (TIMI) flow grade ≥2 Clinical Exclusion Criteria: 1. Planned (staged) intervention in the target vessel 2. ST-segment-elevation MI within 48 hours prior to index procedure 3. Subjects with acute cardiac decompensation or cardiogenic shock 4. Subject with a life expectancy of less than 24 months 5. Impaired renal function (glomerular filtration rate \[GFR\] \<30 mL/min) 6. Documented left ventricular ejection fraction (LVEF) ≤30% 7. Known allergies to acetylsalicylic acid, clopidogrel, prasugrel, ticagrelor, heparin, contrast medium, sirolimus or similar drugs (i.e., ABT-578 \[Zotarolimus\], biolimus, tacrolimus) 8. Relative or absolute contraindication to dual antiplatelet therapy (DAPT) for at least 1 month (e.g., planned surgeries that cannot be delayed) 9. Subject has an indication for chronic oral anticoagulation treatment and a contraindication for concomitant treatment with a P2Y12 inhibitor 10. If femoral access is planned, significant peripheral arterial disease which precludes safe insertion of a 6F sheath 11. Hemoglobin \<9 g/dL 12. Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3 13. White blood cell count \<3,000 cells/mm3 14. Active infection undergoing treatment 15. Clinically significant liver disease 16. Cerebrovascular accident (CVA) within 3 months or has any permanent neurological defect as a result of CVA 17. Subject is receiving oral or intravenous immunosuppressive therapy (e.g., inhaledsteroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus) 18. Subject is unlikely to comply with the follow up requirements, per investigator's assessment 19. Subject currently enrolled in other investigational device or drug trial in which primary endpoint has not been reached 20. Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study Angiographic Exclusion Criteria: All exclusion criteria apply to the target lesion(s) or target vessel(s) 21. Re-stenotic lesion(s), whether due to percutaneous old balloon angioplasty (POBA) or prior stenting 22. True bifurcation lesion (lesion involves both main and side branch\>2.5 mm) with planned treatment of both branches per investigator assessment 23. Angiographic evidence of thrombus in the target vessel 24. Myocardial bridging 25. Target lesion is heavily calcified 26. Diffuse distal disease to target lesion with impaired runoff, TIMI flow \<2 27. Non-target lesion in the target vessel requiring PCI Note: Non-target vessel PCI is allowed at the time of index procedure if performed prior to study intervention and if successful and uncomplicated. For target lesions located in branches of the three main vessels (left anterior descending artery \[LAD\], left circumflex artery \[LCx\], right coronary artery \[RCA\]), the term target vessel refers to the branch and not the main vessel.

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder coronary artery disorder coronary stenosis

As listed by the trial registrant

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

Cardiovascular diseases Coronary artery disease Native coronary artery stenosis

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    24 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • Atlanta VA Medical Center

    NOT_YET_RECRUITING

    Decatur, Georgia, 30033, United States

  • Atlanticare Regional Medical Center

    RECRUITING

    Pomona, New Jersey, 08401, United States

  • Baylor Scott & White The Heart Hospital - Plano

    RECRUITING

    Plano, Texas, 75093, United States

  • Cedars-Sinai Medical Center

    NOT_YET_RECRUITING

    Los Angeles, California, 90048, United States

  • Clearwater Cardiovascular and Interventional Consultants

    RECRUITING

    Clearwater, Florida, 33756, United States

  • Cleveland Clinic

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44195, United States

  • Columbia University/NYP

    NOT_YET_RECRUITING

    New York, New York, 10032, United States

  • Dignity Health - Mercy Gilbert Medical Center

    NOT_YET_RECRUITING

    Gilbert, Arizona, 85297, United States

  • Emory University Hospital /Emory School of Medice

    NOT_YET_RECRUITING

    Atlanta, Georgia, 30322, United States

  • Icahn School of Medicine at Mount Sinai/ Mount Sinai Hospital

    RECRUITING

    New York, New York, 10029, United States

  • Loyola University Medical Center

    NOT_YET_RECRUITING

    Maywood, Illinois, 60153, United States

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10467, United States

  • NC Heart and Vascular Research, LLC

    NOT_YET_RECRUITING

    Raleigh, North Carolina, 27607, United States

  • North Mississippi Medical Center

    NOT_YET_RECRUITING

    Tupelo, Mississippi, 38801, United States

  • North Shore University Hospital - Northwell

    NOT_YET_RECRUITING

    Manhasset, New York, 11030, United States

    Contact Email: •••••@•••••

  • Providence St. Vincent Medical Center

    NOT_YET_RECRUITING

    Portland, Oregon, 97225, United States

  • Tallahassee Research Institute

    NOT_YET_RECRUITING

    Tallahassee, Florida, 32308, United States

  • Tampa General Hospital / University of South Florida

    NOT_YET_RECRUITING

    Tampa, Florida, 33606, United States

  • University Hospitals, Cleveland Medical Center

    NOT_YET_RECRUITING

    Brooklyn, New York, 11215, United States

  • University Hospitals, Cleveland Medical Center

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of Florida Health Sciences Center-Jacksonville

    NOT_YET_RECRUITING

    Jacksonville, Florida, 32209, United States

  • University of Oklahoma Health Science Center

    NOT_YET_RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of Pittsburgh Medical center (UPMC)

    NOT_YET_RECRUITING

    Pittsburgh, Pennsylvania, 15123, United States

  • West Virginia University Heart & Vascular Institute

    NOT_YET_RECRUITING

    Morgantown, West Virginia, 26506, United States

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