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New balloon treatment may be safer for heart patients prone to bleeding

NCT ID NCT05221931

Disease control Sponsor: Samsung Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two treatments for blocked heart arteries in people who are at high risk of bleeding. One treatment uses a drug-coated balloon (DCB) and the other a drug-eluting stent (DES). The goal is to see if the balloon works just as well as the stent while possibly causing less bleeding. Over 1,300 participants are being followed to track heart-related events and bleeding complications.

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 (DCB) or drug-eluting stent (DES)
What this could lead to
If successful, this could offer a safer treatment option for people with coronary artery disease who are at high risk of bleeding, potentially reducing complications like bleeding and heart attacks.
What could go wrong
This is a noninferiority trial, meaning it aims to show DCB is not worse than DES, not necessarily better. Results may not apply to all patients, and long-term outcomes are still unknown.

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

1,359 people

The number who actually took part.

Started

Jul 2022

Expected to finish

Dec 2028

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.

Ages

19 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: 1. Subject must be at least 19 years of age 2. Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily. 3. Patients with at least one lesion with greater than 50% diameter stenosis or fractional flow reserve ≤0.80 requiring revascularization in de-novo coronary artery of reference vessel size ≥2.25 mm 4. Patients with high bleeding risk: one or more of the criteria listed (1) Adjunctive oral anticoagulation treatment planned to continue after PCI (2) Age ≥ 75 years old (3) Baseline Hemoglobin \<11 g/dl (or anemia requiring transfusion during the 4 weeks prior to randomization) (4) Any prior intra-cerebral bleeding (5) Stroke at any time or transient ischemic attack in the previous 6 months. (6) Hospital admission for bleeding during the prior 12 months (7) Non skin cancer diagnosed or treated \< 3 years (8) Planned daily NSAID (other than aspirin) or steroids for \>30 days after PCI (9) Planned surgery that would require interruption of DAPT (within next 12 months) (10) Renal failure defined as calculated creatinine clearance \<40 ml/min or on dialysis (11) Hematological disorders (platelet count \<100,000/mm3 or any coagulation disorder) (12) Severe chronic liver disease defined as patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice (13) Expected non-compliance to prolonged DAPT for other medical reasons Exclusion Criteria: 1. Patients unable to provide consent 2. Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of drug-eluting stents 3. Patients with angiographic findings of (1) Left main coronary artery disease (2) In-stent restenosis is the cause of target lesion (3) Target lesion in bypass graft (4) True bifurcation lesion that requires upfront 2-stenting 4. Patients who have non-cardiac co-morbid conditions with life expectancy \<2 year 5. Patients who may result in protocol non-compliance (site investigator's medical judgment) 6. Patients with cardiogenic shock or cardiac arrest 7. Patients with severe left ventricular systolic dysfunction (ejection fraction \<30%) 8. Patients with severe valvular heart disease requiring open heart surgery 9. Pregnant or lactating women

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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

Contacts and locations

Locations

  • Chonnam National University Hospital

    Gwangju, South Korea

  • Chung-Ang University Gwangmyeong Hospital

    Gwangmyeong, South Korea

  • Chungbuk National University

    Cheongju-si, South Korea

  • Ewha Womans University College of Medicine

    Seoul, South Korea

  • Gangneung Asan Hospital, University of Ulsan College of Medicine

    Gangneung, South Korea

  • Gyeongsang National University Hospital

    Jinju, South Korea

  • Inha University Hospital

    Incheon, South Korea

  • Kangbuk Samsung Hospital

    Seoul, South Korea

  • Keimyung University Dongsan Hospital

    Daegu, South Korea

  • Korea University Ansan Hospital

    Ansan, South Korea

  • Korea University Kuro Hospital

    Seoul, South Korea

  • Samsung Medical Center

    Seoul, South Korea

  • Seoul National University Boramae Medical Center

    Seoul, South Korea

  • Seoul National University Bundang Hospital

    Seongnam-si, South Korea

  • Seoul St. Mary's Hospital, The Catholic University of Korea

    Seoul, South Korea

  • The Catholic University of Korea, Uijeongbu St. Mary's Hospital

    Uijeongbu-si, South Korea

  • Wonju Severance Christian Hospital

    Wŏnju, South Korea

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