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

Official title

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

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.

Detailed description

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.

Interventions

• Device GENOSS® DCB (Paclitaxel-coated PTCA balloon catheter)
  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 tre
• Device Second, Third Generation Drug-Eluting Coronary Stent System
  Contemporary drug-eluting stents (DES) with either biodegradable or non-biodegradable (durable) polymer coatings, covering all regulatory-approved, thin-strut metal platforms.

Primary outcome measures

• Net Clinical outcome (NCO) [Time frame: at 12 months after procedure]

Secondary outcome measures (12)

• Net Clinical outcome (NCO) [Time frame: at 24, and 36 months after procedure]
• Major adverse cardiovascular events (MACEs) [Time frame: at 24, and 36 months after procedure]
• Major adverse cardiac events (MACE) [Time frame: at 24, and 36 months after procedure]
• Major bleeding [Time frame: at 24, and 36 months after procedure]
• All-cause death [Time frame: at 24, and 36 months after procedure]
• Cardiac death [Time frame: at 24, and 36 months after procedure]
• Myocardial infarction [Time frame: at 24, and 36 months after procedure]
• Target vessel-myocardial infaction (TV-MI) [Time frame: at 24, and 36 months after procedure]
• Target lesion revascularization (TLR) [Time frame: at 24, and 36 months after procedure]
• Target vessel revascularization (TVR) [Time frame: at 24, and 36 months after procedure]
• Definite or probable stent thrombosis [Time frame: at 24, and 36 months after procedure]
• Ischemic or hemorrhagic stroke [Time frame: at 24, and 36 months after procedure]

Eligibility criteria

Inclusion criteria

• 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).
• 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.
• 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.
• 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).
• Target lesions suitable for treatment with either drug-eluting stents (DES) or drug-coated balloons (DCB).
• Patients who have voluntarily provided written informed consent and are willing and able to comply with all protocol-specified requirements.

Exclusion criteria

• Cardiogenic shock or patients requiring mechanical or pharmacological circulatory support.
• Patients with a life expectancy of less than 2 years due to comorbid conditions.
• Patients who are currently participating or planning to participate in other interventional clinical trials, excluding observational studies.
• Women who are pregnant or have childbearing potential.
• 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.
• Patients with a target lesion located within a saphenous vein graft (SVG) or an arterial graft.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07539324 · CIP-DS1001-4

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗