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

NCT07539324 | Not Yet Recruiting

• 1 other identifier: CIP-DS1001-4
• Study Type: interventional
• Target: 892
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Multi Vessel Coronary Artery Disease; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• 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.

  at 12 months after procedure

Secondary Outcomes (12)

• Net Clinical outcome (NCO)

  at 24, and 36 months after procedure

• Major adverse cardiovascular events (MACEs)

  at 24, and 36 months after procedure

• Major adverse cardiac events (MACE)

  at 24, and 36 months after procedure

• Major bleeding

  at 24, and 36 months after procedure

• All-cause death

  at 24, and 36 months after procedure

Study Arms (2)

GENOSS® DCB

EXPERIMENTAL

Paclitaxel-coated PTCA Balloon Catheter

Device: GENOSS® DCB (Paclitaxel-coated PTCA balloon catheter)

Second, Third Generation Drug-Eluting Coronary Stent System

ACTIVE COMPARATOR

All-comer current-generation biodegradable or durable polymer-based drug-eluting stents (DES)

Device: Second, Third Generation Drug-Eluting Coronary Stent System

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).

GENOSS® DCB

Second, Third Generation Drug-Eluting Coronary Stent System DEVICE

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

Second, Third Generation Drug-Eluting Coronary Stent System

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genoss Co., Ltd.: lead

Central Study Contacts

Eun-Seok Shin, Cardiology

CONTACT

010-6319-4025; sesim1989@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): July 31, 2032
• Last Updated: April 20, 2026

Record last verified: 2026-04