Clinical Impact of DCB-based Versus DES-based Intervention in Patients With MVCAD

Clinical Impact of Drug-Coated-Balloon-based Versus Drug-Eluting-Stent-based Intervention in Patients With Multivessel Coronary Artery Disease : A Prospective, Multicenter, Active-controlled, Randomized, Single-blind, Investigator-initiated Clinical Trial

This study aimes to compare the clinical outcomes of drug-coated balloon-based percutaneous coronary intervention (DCB-based PCI) and drug-eluting stent-based percutaneous coronary intervention (DES-based PCI) in patients with multivessel coronary artery lesions measuring 2.25 mm to 4.0 mm in diameter through a prospective, multicenter, active-controlled, randomized, investigator-initiated clinical trial.

This study is a prospective, multicenter, active-controlled, randomized, single-blind, investigator-initiated clinical trial in patients with multivessel coronary artery disease.

The clinical outcomes of the DCB-based PCI group and the DES-based PCI group, assigned through 1:1 random assignment, will be compared, and approximately 9 hospitals will participate.

The primary endpoint is the Net Clinical Outcome (NCE) at 12 months after the procedure, and secondary endpoints will be followed up to 36 months.

Inclusion Criteria:

1. Male or female adults aged 20 years or older with stable angina, silent myocardial ischemia, unstable angina, or non-ST-segment elevation myocardial infarction (NSTEMI).
2. In cases of ST-segment elevation myocardial infarction (STEMI), patients who have undergone successful primary percutaneous coronary intervention (PCI) without complications, at least 48 hours post-procedure, and whose target lesion(s) show no evidence of thrombus.
3. Patients with multivessel coronary artery disease, defined as angiographic stenosis of 50% in at least two major epicardial coronary arteries requiring PCI as determined by the investigator.
4. Reference vessel diameter (RVD) of the target lesion(s) between 2.25 mm and 4.0 mm by visual estimation or quantitative coronary angiography (QCA).
5. Target lesions suitable for treatment with either drug-eluting stents (DES) or drug-coated balloons (DCB).
6. Patients who have voluntarily provided written informed consent and are willing and able to comply with all protocol-specified requirements.

Exclusion Criteria:

1. Cardiogenic shock or patients requiring mechanical or pharmacological circulatory support.
2. Patients with a life expectancy of less than 2 years due to comorbid conditions.
3. Patients who are currently participating or planning to participate in other interventional clinical trials, excluding observational studies.
4. Women who are pregnant or have childbearing potential.
5. Patients with a known hypersensitivity or allergy to contrast media, L-605 Cobalt-Chromium (Co-Cr) alloy, PLA and PLGA polymers, shellac, Vitamin E-TPGS, paclitaxel, or sirolimus.
6. Patients with a target lesion located within a saphenous vein graft (SVG) or an arterial graft.
7. Patients with target vessels/lesions that are excessively tortuous, angulated, or severely calcified, such that pre-dilatation cannot be performed or has failed, making the application of the investigational medical device difficult.