DCB-based PCI vs DES-based PCI in multivessel coronary disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, single-blind trial comparing paclitaxel-coated balloon catheter PCI to contemporary DES PCI in adults with multivessel coronary artery disease and reference vessel diameters of 2.25 to 4.0 mm. Participants are assigned 1:1 to receive either DCB-based PCI or DES-based PCI, with 9 hospitals anticipated to enroll. The primary outcome is time to first Net Clinical Outcome within 12 months, and secondary outcomes extend to 36 months. Lesion preparation is performed after randomization according to the assigned treatment strategy. The study is investigator-initiated with Genoss as lead sponsor.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for participation in this clinical study.

1. Adults aged ≥20 years with stable angina, silent myocardial ischemia, unstable angina, or non-ST-segment elevation myocardial infarction (NSTEMI).
2. Patients with ST-segment elevation myocardial infarction (STEMI) who have undergone successful and uncomplicated primary percutaneous coronary intervention (PCI), are at least 48 hours after the index procedure, and have no evidence of thrombus in the lesion(s) intended for treatment.
3. Patients with multivessel coronary artery disease, defined as ≥50% diameter stenosis by coronary angiography, in whom the investigator determines that PCI is indicated in at least two major epicardial coronary arteries.
4. Patients with a reference vessel diameter (RVD) of ≥2.25 mm and ≤4.0 mm, as assessed by coronary angiography.
5. Patients in whom the investigator determines, based on coronary angiographic findings and clinical assessment, that PCI of the target lesion(s) is technically feasible.
6. Patients who voluntarily provide written informed consent to participate in the clinical trial and are willing and able to comply with the study requirements.

Exclusion Criteria:

Patients meeting any of the following criteria will be excluded from enrollment.

1. Cardiogenic shock or the need for mechanical or pharmacological circulatory support.
2. Life expectancy of ≤2 years due to concomitant medical conditions.
3. Current participation in, or planned participation in, another interventional clinical trial, excluding observational studies.
4. Pregnant women or women of childbearing potential.
5. Known hypersensitivity or allergy to contrast media, L-605 cobalt-chromium (Co-Cr) alloy, PLA or PLGA polymers, shellac, Vitamin E-TPGS, paclitaxel, or sirolimus.
6. A target lesion located within a saphenous vein graft or an arterial graft.
7. Patients in whom the investigator determines that PCI cannot be performed because of the anatomical characteristics of the target vessel or lesion or the patient's clinical condition.

Where it's running

• Ulsan University Hospital
  Ulsan, South Korea Recruiting

Study contacts

• Study coordinator: Eun-Seok Shin, MD, PhD
• Email: sesim1989@gmail.com
• Phone: +82-52-250-8838

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating complete revascularization in patients with multivessel coronary artery disease

  This study is testing if a specific heart procedure can improve health outcomes for people with multiple blocked arteries who experience chest pain or other heart issues.

  Recruiting Erasmus Medical Center · Rotterdam, South Holland · NCT05230446

• Pilates breathing vs diaphragmatic breathing after PCI

  This study tests whether Pilates breathing or diaphragmatic breathing helps improve oxygen levels and heart-rate variability in people who just had PCI.

  Recruiting Foundation University Islamabad · Rawalpindi · NCT07872098

• Aspirin 50 mg vs 100 mg with a P2Y12 inhibitor after PCI

  This trial tests whether a 50 mg daily aspirin dose, when used with a P2Y12 inhibitor after PCI, works as well as 100 mg with similar safety for people staying on DAPT for 12 months.

  Recruiting Jilin University · Changchun, Jilin · NCT07846462

• See if stopping long-term aspirin is as good as continuing it in older adults with stable ischemic heart disease

  In adults 65 and older with stable ischemic heart disease, this trial tests whether stopping daily low-dose aspirin is not worse than continuing it.

  Recruiting at 2 sites Phase 4 Odense University Hospital · Copenhagen and 1 other locations · NCT07795398

• Dual antihypertensive combinations after PCI: ARB + thiazide versus ARB + amlodipine

  This trial tests two blood pressure treatment combos after a stent procedure in people with hypertension and coronary disease to see which regimen better controls blood pressure and improves symptoms.

  Recruiting National Medical Research Center for Therapy and Preventive Medicine · Moscow · NCT07683585

• Coronary thrombus modification to reduce microvascular damage during STEMI care

  This study tests whether modifying the clot in the heart arteries during primary PCI can lessen microvascular damage and myocardial injury in STEMI patients.

  Recruiting Odense University Hospital · Odense · NCT07646977

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.