Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Balloon or stent? major trial tests safer option for clogged heart arteries

NCT ID NCT05846893

Disease control Sponsor: B. Braun Medical Industries Sdn. Bhd. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests whether a drug-coated balloon is as safe and effective as a drug-eluting stent for people with large coronary artery disease. About 1,400 participants from multiple countries will be randomly assigned to one of the two treatments. The goal is to see which approach better prevents death, heart attacks, repeat procedures, or major bleeding.

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 1,436 people

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

Started

Sep 2023

Expected to finish

Jan 2029

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: * Patient-related: 1. Patient must be ≥ 18 years of age 2. Patient is able to verbally confirm understanding of the study aim, risks, benefits, and treatment alternatives of receiving DCB or DES and he/she or his/her legally authorized representative provides written informed consent prior to any study-related procedure 3. (i) Clinical evidence of angina, and/or (ii) an abnormal functional study demonstrating myocardial ischemia due to the target lesion(s), or (iii) acute coronary syndrome \[unstable angina or non-ST-elevation myocardial infarction (NSTEMI) or uneventful STEMI (≥ 48 hours after primary PCI and no sign of thrombus in lesion(s) to treat)\] 4. Patient with lesions suitable for PCI with a DCB (and/or DES) according to the Instructions for Use 5. Patient is able to comply with the study protocol and agrees to undergo the clinical follow-up of 30 days, 6 months, 12 months, 24 months, and 36 months * Lesion-related: 1. Presence of significant de novo large vessel coronary artery disease (reference vessel diameter ≥3.0 mm by visual estimation) with either ≥ 70% diameter stenosis or intermediate ≥ 50% to \<70% diameter stenosis with abnormal functional test or symptom of ischemia 2. Successful lesion preparation. For randomisation, the lesion must satisfy the following criteria after optimal balloon angioplasty: no flow-limiting dissection (TIMI=3), and residual stenosis is ≤ 30% * Multivessel disease with two or more vessels showing diameter stenosis of 50% or more is not an exclusion as long as it fulfills all study's eligibility criteria. * In diffuse lesion, inclusion is possible if the proximal reference vessel diameter is 3.0 mm or more. Exclusion Criteria: * Patient-related: 1. Intolerance or allergy to Paclitaxel and/or the delivery matrix (main ingredient: Iopromide) 2. Severe allergy to contrast media 3. Recent STEMI (ongoing or \< 48 hours after primary PCI and/or has sign of thrombus in lesion(s) to treat) 4. NSTEMI hemodynamically unstable 5. Known left ventricular ejection fraction of \<30% 6. Inability to take dual antiplatelet therapy or anticoagulation, or single antiplatelet therapy for at least six months 7. Non-cardiac co-morbid conditions that may result in protocol non-compliance and inability of patient to complete the study (per the site investigator's medical judgment) 8. Patient with concomitant medical illnesses that require cytostatic, radiation therapy or renal replacement therapy 9. Patient who is currently/ planning to participate in another clinical trial when such participation could confound the treatment or outcomes of this study, except for observational registry 10. Pregnancy or lactation 11. Patient under administrative or judicial custody * Lesion-related: 1. Small vessel disease, defined as \<3.0 mm of reference vessel diameter by visual estimation 2. In-stent restenosis lesions for study lesions 3. Patient will be excluded if meet any of the following angiographic exclusion criteria after lesion preparation: (i) Flow limiting dissection with TIMI flow \< III (ii) Residual diameter stenosis \>30% \* The case of persistent ischemic symptoms/signs is up to the operator's decision 4. Lesions which are untreatable with PCI or other interventional techniques and coronary artery spasm in the absence of a significant stenosis 5. Left main disease or aorta-ostial lesion requiring revascularization 6. Severely calcified or tortuous vessels precluding DCB or DES application 7. Prior Coronary Artery Bypass Graft (CABG)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute coronary syndrome are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

acute coronary syndrome Angina Pectoris cardiovascular disorder Constriction, Pathologic coronary artery disorder Coronary Occlusion coronary stenosis heart disorder ischemic disease myocardial ischemia

As listed by the trial registrant

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

Acute coronary syndrome Coronary artery disease Coronary stenosis De novo stenosis Myocardial ischemia

Contacts and locations

Locations

  • Cardiac Vascular Sentral Kuala Lumpur

    Kuala Lumpur, Kuala Lumpur, 50470, Malaysia

  • Chang Gung Memorial Hospital

    Taoyuan, 33305, Taiwan

  • Chonnam National University Hospital

    Donggu, Gwangju, 61469, South Korea

  • Far Eastern Memorial Hospital

    New Taipei City, 220216, Taiwan

  • Gyeongsang National University Changwon Hospital

    Changwon, Gyeongsangnam-do, 51472, South Korea

  • Inje University Ilsan Paik Hospital

    Goyang-si, Gyeonggi-do, 10380, South Korea

  • Kangbuk Samsung Hospital

    Seoul, Seoul, 13631, South Korea

  • Kangwon National University Hospital

    Chuncheon, Gangwon-do, 24289, South Korea

  • Keimyung University Dongsan Hospital

    Daegu, Daegu, 42601, South Korea

  • Khoo Teck Puat Hospital

    Singapore, 768828, Singapore

  • Korea University Ansan Hospital

    Ansan-si, Gyeonggi-do, 15355, South Korea

  • Korea University Guro Hospital

    Seoul, 08308, South Korea

  • National Heart Centre Singapore

    Singapore, 169609, Singapore

  • National Heart Institute Malaysia

    Kuala Lumpur, Kuala Lumpur, 50400, Malaysia

  • Queen Elizabeth II Hospital

    Kota Kinabalu, Sabah, 88300, Malaysia

  • Sarawak Heart Center

    Kuching, Sarawak, 94300, Malaysia

  • Sultan Idris Shah Serdang Hospital

    Kajang, Selangor, 43000, Malaysia

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • Tan Tock Seng Hospital

    Novena, 308433, Singapore

  • Ulsan University Hospital

    Donggu, Ulsan, 44033, South Korea

  • University Malaya Medical Centre

    Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

More trials for these conditions

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