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New balloon treatment aims to clear blocked stents without extra surgery

NCT ID NCT04647253

Disease control Sponsor: Boston Scientific Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 4 times

Summary

This study tests a special balloon coated with a drug to treat heart arteries that have narrowed again after a stent was placed. About 600 adults with this condition will be randomly assigned to receive either the drug-coated balloon or a standard balloon procedure. The goal is to see if the new balloon is safer and more effective at keeping the artery open and preventing future heart problems.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

600 people

The number who actually took part.

Started

May 2021

Expected to finish

Sep 2027

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.

Clinical Inclusion Criteria * Subject must be at least 18 years of age * Subject (or legal guardian) understands the trial requirements and the treatment procedures, and provides written informed consent before any trial-specific tests or procedures are performed * Subject is eligible for percutaneous coronary intervention (PCI) * Subject is willing to comply with all protocol-required follow-up evaluation * Women of child-bearing potential must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure Angiographic Inclusion Criteria (visual estimate) * In-stent restenosis in a lesion previously treated with either a drug-eluting stent or bare metal stent, located in a native coronary artery with a visually estimated reference vessel diameter (RVD) \> 2.0 mm and ≤ 4.0 mm. * Target lesion length must be \< 26 mm (by visual estimate) and must be covered by only one balloon. * Target lesion must have visually estimated stenosis \> 50% and \< 100% in symptomatic patients (\>70% and \<100% in asymptomatic patients) prior to lesion pre-dilation. * Target lesion must be successfully pre-dilated. o Note: Successful predilation/pretreatment refers to dilation with a balloon catheter of appropriate length and diameter, or pretreatment with directional or rotational coronary atherectomy, laser or cutting/scoring balloon with no greater than 50% residual stenosis and no dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C. Thrombolysis in Myocardial Infarction (TIMI) grade flow in the target lesion must be \>2 * If a non-target lesion is treated, it must be treated first and must be deemed a success. * Note: Successful treatment of a non-target lesion is defined as a residual stenosis of ≤ 30% in 2 near-orthogonal projections with TIMI 3 flow, as visually assessed by the physician, without the occurrence of prolonged chest pain or ECG changes consistent with MI. Clinical Exclusion Criteria * Subject has other serious medical illness (e.g. cancer, congestive heart failure) that may reduce life expectancy to less than 24 months. * Subject has current problems with substance abuse (e.g. alcohol, cocaine, heroin, etc.). * Subject has planned procedure that may cause non-compliance with the protocol or confound data interpretation. * Subject is participating in another investigational drug or device clinical study that has not reached its primary endpoint. * Subject intends to participate in another investigational drug or device clinical study within 12 months after the index procedure. * Woman who is pregnant or nursing. (A pregnancy test must be performed within 7 days prior to the index procedure, except for women who definitely do not have child-bearing potential.) * Left ventricular ejection fraction known to be \< 25%. * Subject had PCI or other coronary interventions within the last 30 days. * Planned PCI or CABG after the index procedure. * STEMI or QWMI \<72h prior to the index procedure. * Cardiogenic shock (SBP \< 80 mmHg requiring inotropes, IABP or fluid support). * Known allergies against paclitaxel or other components of the used medical devices. * Known hypersensitivity or contraindication for contrast dye that in the opinion of the investigator cannot be adequately pre-medicated. * Intolerance to antiplatelet drugs, anticoagulants required for procedure. * Platelet count \< 100k/mm3 (risk of bleeding) or \> 700k/mm3. * Subject with renal insufficiency (creatinine ≥2.0 mg/dl) or failure (dialysis dependent). * Subject has suspected or proven COVID-19 at present or within the past 4 weeks with resolution of symptoms. Angiographic Exclusion Criteria (visual estimate) * Target lesion is located within a bifurcation with planned treatment of side branch vessel. * Target lesion is located within a saphenous vein or arterial graft. * Thrombus present in the target vessel * \> 50% stenosis of an additional lesion proximal or clinically significant distal (\>2.0mm RVD) to the target lesion. * Patient with unprotected left main coronary artery disease. (\>50% diameter stenosis)

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Conditions

The condition(s) this trial relates to.

coronary restenosis

As listed by the trial registrant

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

In-stent restenosis

Contacts and locations

Locations

  • Baylor Heart and Vascular Hospital

    Dallas, Texas, 75226, United States

  • Bergan Cardiology

    Omaha, Nebraska, 68124, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Carondelet Medical Group St. Mary's Hospital

    Tucson, Arizona, 85745, United States

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Centennial Medical Center

    Nashville, Tennessee, 37203, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

  • Evanston Hospital

    Evanston, Illinois, 60201, United States

  • Heart Hospital of Austin

    Austin, Texas, 78756, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042, United States

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753, United States

  • Lindner Center for Research and Education at Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Methodist North Hospital

    Memphis, Tennessee, 38104, United States

  • Montefiore Medical Center

    New York, New York, 10467, United States

  • Northside Hospital

    Lawrenceville, Georgia, 30046, United States

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121, United States

  • Overland Park Regional Medical Center

    Overland Park, Kansas, 66211, United States

  • Regions Hospital

    Saint Paul, Minnesota, 55101, United States

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • San Francisco Veterans Affairs Medical Center

    San Francisco, California, 94121, United States

  • South Denver Cardiology

    Littleton, Colorado, 80210, United States

  • St. Anthony Hospital

    Lakewood, Colorado, 80216, United States

  • St. Francis Hospital

    Roslyn, New York, 11576, United States

  • St. Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111, United States

  • Stanford University Medical Center

    Stanford, California, 94305, United States

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • UPMC Pinnacle Health

    Wormleysburg, Pennsylvania, 17053, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of California San Diego

    La Jolla, California, 92037, United States

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908, United States

  • University of Washington

    Seattle, Washington, 98195, United States

  • Wake Medical Center

    Raleigh, North Carolina, 27610, United States

  • Wellstar Kennestone Hospital

    Marietta, Georgia, 30060, United States

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