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New balloon treatment could open clogged small heart arteries without stents

NCT ID NCT05946629

Disease control Sponsor: M.A. Med Alliance S.A. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Updated 3 times

Summary

This study tests a special balloon coated with medicine to treat narrowed small arteries in the heart. About 960 adults with coronary artery disease will receive either this balloon or standard treatment. The goal is to see if the balloon safely opens the artery and reduces the need for repeat procedures.

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 960 people

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

Started

Oct 2023

Expected to finish

Jun 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: * Clinical Inclusion Criteria Subjects must meet all of the following clinical criteria to participate in the trial: 1. Subject is ≥ 18 years (or the minimum legal age as required by local regulations). 2. Female subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before the procedure or are using a contraceptive device or drug. 3. Subject presents with chronic coronary syndromes \[CCS\] (manifest as documented angina or positive functional testing), unstable angina or stabilized non-ST elevation myocardial infarction (NSTEMI) (biomarkers stabilized or down trending) with an indication for PCI and planned intervention. 4. Subject can tolerate dual antiplatelet therapy with aspirin, plus either Clopidogrel, Prasugrel, or Ticagrelor. (Note: For subjects requiring oral anticoagulation, aspirin may be omitted based on investigator discretion). 5. Subject has life expectancy \> 1 year in the opinion of the investigator. 6. Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations. PK Sub- Study Inclusion Criteria: Subjects must meet all of the main protocol inclusion criteria to participate in the PK sub-study. Subjects must also meet the following additional PK sub-study inclusion criteria: 1\. Subject is willing and able to provide informed consent for the PK sub-study and comply with the PK sub-study procedures and required follow-up evaluations. Imaging Inclusion Criteria Subject's target lesion(s) must meet all of the following angiographic criteria for the subject to participate in the trial: 1. A single, target lesions that meet criteria can be treated in a single vessel. No non-target lesions can be treated within the target vessel in the index procedure. Non-target lesions within the target vessel can be staged for treatment \> 30 days from the index procedure. 2. Up to two (2) non-target lesions in up to two (2) non-target vessels may be treated, but successful PCI of the non-target lesions must be completed before randomization and treatment of the target lesion. 3. Target lesion is ≤ 36 mm in length. 4. Target lesion has diameter stenosis \> 50% and ≤ 99% with distal flow at least thrombolysis in myocardial infarction (TIMI) 2. 5. Target vessel has RVD of ≥ 2.00 mm and ≤ 2.75 mm \[by visual assessment\]. 6. Target lesion is within a native coronary artery or major branch. 7. A target lesion within a bifurcation is allowed only if a single vessel (either main vessel or side branch) is to be treated. 8. The identified target lesion has high probability for successful treatment with approved pre-treatment techniques and DEB alone based on Investigator assessment. Exclusion Criteria: * Clinical Exclusion Criteria Subjects who meet any of the following clinical criteria will be excluded from the trial: 1. Subject with known hypersensitivity or allergy to Sirolimus or its analogues. 2. Subject presents with NSTEMI and rising biomarkers, or ongoing chest pain or is hemodynamically instable. 3. Subject with history of ST-elevation myocardial infarction (STEMI) within 30 days of the index procedure. 4. Subject with planned major surgery within 30 days following the index procedure. 5. Subject with planned treatment of lesion involving aorto-ostial location. 6. Subject with PCI of a non-target vessel within ± 30 days of the index procedure. 7. Subject with history (within 6 months prior to index procedure) of New York Heart Association (NYHA) class III or IV heart failure. 8. Subject with history of active peptic ulcer or gastrointestinal bleeding within 6 months of the index procedure or other inability to comply with the recommended duration of dual antiplatelet therapy (DAPT). 9. Subject is pregnant, breast-feeding or a woman of childbearing potential who plans pregnancy up to 1 year following index procedure. 10. Subjects with current documented left ventricular ejection fraction (LVEF) \< 30%. 11. Subject is considered not able to tolerate at least 30 seconds of coronary occlusion for the target lesion treated. 12. Subjects is currently participating in another investigational drug or device study that has not completed primary endpoint follow-up. 13. Subject with definite clinically active COVID-19 infection defined as a positive COVID test within 24 hours of index procedure. 14. Subject has chronic renal insufficiency (dialysis dependent, or glomerular filtration rate \[GFR\] ≤ 30 ml/min/1.73 m2 within 30 days of index procedure) or had undergone renal transplantation. PK Sub-Study Exclusion Criteria: Subjects must meet none of the main protocol exclusion criteria to participate in the PK sub-study. Subjects will be excluded if any of the following additional PK sub-study exclusion criteria are met: 1. Any limus family (Zotarolimus, Everolimus, Sirolimus etc.) eluting device has been placed/used in any part of the body within 3 months prior to the index procedure including non-target lesion(s) treated during the index procedure. 2. Planned intervention with any limus family (Zotarolimus, Everolimus, Sirolimus etc.) eluting device anywhere in the body within 6 months after the index procedure. Note: staged procedures \>30 days after index procedure (Exclusion #6 of the main protocol) are permitted only in the main protocol, and are not permitted in this PK sub-study. 3. The subject is taking or has taken within the last 3 months any limus family medication(s) for any reason. 4. Subject is concurrently enrolled in the main protocol angiographic registry. 5. Subjects who are taking strong CYP3A4 Inhibitors within 14 days before the index procedure or plan to take the strong inhibitors during the study period. Strong inhibitors include: cobicistat; ritonavir; indinavir and ritonavir; itraconazole; ketoconazole; lopinavir and ritonavir; paritaprevir and ritonavir and ombitasvir (and/or dasabuvir); posaconazole; saquinavir and ritonavir; tipranavir and ritonavir; elvitegravir and ritonavir; telithromycin; voriconazole; ceritinib; clarithromycin; idealalisib; nefazodone; nelfinavir. 6. Subjects who are taking strong CYP3A4 Inducers within 14 days before the index procedure or plan to take the strong inducers during the study period. Strong inducers include apalutamide; carbamazepine; enzalutamide; ivosidenib; lumacaftor and ivacaftor; mitotane; phenytoin; rifampin; St. John's wort. * Angiographic Exclusion Criteria Subject whose target lesion(s) meet any of the following angiographic criteria will be excluded from the trial: 1. Target lesion is totally occluded or has evidence of thrombus. 2. Target lesion is located in the left main or any arterial or venous graft. 3. Target lesion is in a side branch that is "jailed" by a main vessel stent. 4. In stent restenosis

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Conditions

The condition(s) this trial relates to.

Angina, Stable coronary artery disorder Non-ST Elevated Myocardial Infarction

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

    68 sites in 2 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

  • AdventHealth Orlando

    RECRUITING

    Orlando, Florida, 32803, United States

  • Advocate Aurora St. Luke's

    RECRUITING

    Milwaukee, Wisconsin, 53215, United States

  • Advocate Christ Medical Center

    RECRUITING

    Oak Lawn, Illinois, 60453, United States

  • Advocate Good Samaritan Hospital

    RECRUITING

    Downers Grove, Illinois, 60515, United States

  • Archbold Memorial Hospital

    RECRUITING

    Thomasville, Georgia, 31792, United States

  • Atlanta VA

    RECRUITING

    Atlanta, Georgia, 30033, United States

  • Baptist Health Lexington

    RECRUITING

    Lexington, Kentucky, 40503, United States

  • Baylor Scott and White - Dallas

    RECRUITING

    Dallas, Texas, 75246, United States

  • Baylor Scott and White - Temple

    RECRUITING

    Temple, Texas, 76508, United States

  • Baylor Scott and White Plano

    RECRUITING

    Plano, Texas, 75093, United States

  • Baystate Medical Center

    RECRUITING

    Springfield, Massachusetts, 01199, United States

  • Beth Israel Deaconess

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Brigham & Women's

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • CAMC

    RECRUITING

    Charleston, West Virginia, 25304, United States

  • CHI Memorial

    RECRUITING

    Chattanooga, Tennessee, 37404, United States

  • CISD Sharp Chula Vista

    RECRUITING

    Chula Vista, California, 91911, United States

  • Cardiovascular Institute of the South

    RECRUITING

    Houma, Louisiana, 70360, United States

  • Cardiovascular Research Institute of Kansas

    RECRUITING

    Wichita, Kansas, 67226, United States

  • Carle Foundation Hospital

    RECRUITING

    Urbana, Illinois, 61801, United States

  • Cedars Sinai

    RECRUITING

    Los Angeles, California, 90048, United States

  • ClinRe

    RECRUITING

    Thornton, Colorado, 80023, United States

  • Colorado Heart and Vascular

    RECRUITING

    Golden, Colorado, 80401, United States

  • Emory

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Englewood Health

    RECRUITING

    Englewood, New Jersey, 07631, United States

  • HCA Centennial

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • HCA Chippenham

    RECRUITING

    Richmond, Virginia, 23225, United States

  • HCA Florida JFK

    WITHDRAWN

    Atlantis, Florida, 33462, United States

  • HCA Largo

    RECRUITING

    Largo, Florida, 33770, United States

  • HCA Los Robles

    RECRUITING

    Thousand Oaks, California, 91360, United States

  • HCA Northside

    RECRUITING

    St. Petersburg, Florida, 33709, United States

  • HCA Overland Park

    RECRUITING

    Overland Park, Missouri, 66211, United States

  • HCA Trinity

    RECRUITING

    Trinity, Florida, 34655, United States

  • Hamilton Medical Center

    RECRUITING

    Dalton, Georgia, 30720, United States

  • Harbor UCLA

    RECRUITING

    Torrance, California, 90502, United States

  • Hendrick Health

    RECRUITING

    Abilene, Texas, 79601, United States

  • Herzzentrum Dresden

    RECRUITING

    Dresden, 01307, Germany

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Intermountain Health - Salt Lake City

    RECRUITING

    Murray, Utah, 84107, United States

  • Johns Hopkins

    WITHDRAWN

    Baltimore, Maryland, 21287, United States

  • Lifespan Rhode Island & Miriam

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • Manatee Memorial

    RECRUITING

    Bradenton, Florida, 34208, United States

  • Mass General

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mease Countryside Hospital

    RECRUITING

    Clearwater, Florida, 34695, United States

  • MedStar Washington Hospital Center

    RECRUITING

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

  • MediClin Herzzentrum Lahr

    RECRUITING

    Lahr, 77933, Germany

  • Medical City of Fort Worth

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • Minneapolis Heart Institute

    RECRUITING

    Minneapolis, Minnesota, 55407, United States

  • Minneapolis VA Medical Center

    RECRUITING

    Minneapolis, Minnesota, 55417, United States

  • NC Heart and Vascular

    RECRUITING

    Raleigh, North Carolina, 27607, United States

  • North Mississippi Medical Center

    RECRUITING

    Tupelo, Mississippi, 38801, United States

  • Oklahoma Heart

    RECRUITING

    Oklahoma City, Oklahoma, 73120, United States

  • Pali Momi Medical Center

    RECRUITING

    ‘Aiea, Hawaii, 96701, United States

  • Penn State Health Hershey & Berks

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Piedmont Heart Institute

    RECRUITING

    Atlanta, Georgia, 30309, United States

  • St. Bernards

    RECRUITING

    Jonesboro, Arkansas, 72401, United States

  • St. Louis Heart and Vascular

    RECRUITING

    St Louis, Missouri, 63136, United States

  • Stony Brook University Hospital

    RECRUITING

    Stony Brook, New York, 11794, United States

  • Texas Health

    RECRUITING

    Dallas, Texas, 75231, United States

  • The Lindner Research Center at Christ

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • UH Cleveland

    RECRUITING

    Cleveland, Ohio, 44120, United States

  • UKB Berlin

    RECRUITING

    Berlin, 12683, Germany

  • UPMC Pinnacle

    RECRUITING

    Mechanicsburg, Pennsylvania, 17050, United States

  • University of Florida, Jacksonville

    RECRUITING

    Jacksonville, Florida, 32209, United States

  • University of Iowa Medical Center

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Maryland

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Nebraska

    RECRUITING

    Omaha, Nebraska, 68198, United States

  • University of Nebraska

    RECRUITING

    Chattanooga, Tennessee, 37404, United States

  • Universitäts-Herzzentrum Freiburg

    RECRUITING

    Bad Krozingen, 79189, Germany

  • WellSpan York Hospital

    RECRUITING

    York, Pennsylvania, 17403, United States

  • Yale New Haven Hospital

    RECRUITING

    New Haven, Connecticut, 06520, United States

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