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

N/ANot Yet RecruitingNCT07539324

Genoss Co., Ltd.892 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

892

Conditions

Multi Vessel Coronary Artery Disease Percutaneous Coronary Intervention

Interventions

GENOSS® DCB (Paclitaxel-coated PTCA balloon catheter)DEVICE

GENOSS DCB is designed to improve the lumen diameter and to reduce restenosis in the treatment of lesions in native coronary arteries. GENOSS DCB has been demonstrated to reduce restenosis for the treatment of in-stent restenosis and de-novo lesions in coronary arteries narrowed by atherosclerosis. GENOSS DCB is designed to improve the lumen diameter and to reduce restenosis in the treatment of lesions in native coronary arteries. GENOSS DCB has been demonstrated to reduce restenosis for the treatment of in-stent restenosis and de-novo lesions in coronary arteries narrowed by atherosclerosis. GENOSS DCB's active drug coating is located on the surface of the balloon, which contains 3ug Paclitaxel per 1mm2. The drug is embedded in a physiologically harmless and degradable delivery matrix (main component: shellac and vitamin E-TPGS).

Second, Third Generation Drug-Eluting Coronary Stent SystemDEVICE

Contemporary drug-eluting stents (DES) with either biodegradable or non-biodegradable (durable) polymer coatings, covering all regulatory-approved, thin-strut metal platforms.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Net Clinical outcome (NCO)

The primary endpoint is the net clinical outcome, defined as a composite of all-cause death, non-fatal myocardial infarction, clinically driven target vessel revascularization (TVR), and BARC (Bleeding Academic Research Consortium) type 2 to 5 bleeding.

Time frame: at 12 months after procedure

Secondary Outcomes

Net Clinical outcome (NCO)

Net Clinical Outcome (NCO) is defined as a composite of all-cause death, non-fatal myocardial infarction, clinically driven target vessel revascularization (TVR), and BARC (Bleeding Academic Research Consortium) type 2 to 5 bleeding.