Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions

NCT ID: NCT05096442

Last Updated: 2024-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2023-11-21

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of a novel Paclitaxel-coated balloon (Genoss® DCB) by demonstrating non-inferiority to in-lesion late lumen loss at 6 months after the procedure in Korean patients with coronary de novo lesions compared with a product of the same category (SeQuent® Please NEO).

Detailed Description

In a randomized controlled trial to compare with the same-category drug device (SeQuent® Please NEO), 204 patients with coronary de novo lesions were recruited from a total of 12 institutions, and the enrolled subjects were 1: 1 through randomization.

The ratio was assigned to the test group and the control group, and each of the test or control devices was assigned to receive the procedure.

The primary end point is the in-lesion late lumen loss of the target lesion at 6 months after the procedure, and the secondary end point is the target vessel failure (Composite of cardiac death, TV-MI, and ID-TVR) at 6 and 12 months after the procedure.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Genoss® DCB

Paclitaxel Coated PTCA Balloon Catheter

Group Type: EXPERIMENTAL

GENOSS® DCB

Intervention Type: DEVICE

Drug Coated Balloon

SeQuent® Please NEO

Paclitaxel Coated PTCA Balloon Catheter

Group Type: ACTIVE_COMPARATOR

SeQuent® Please NEO

Intervention Type: DEVICE

Drug Coated Balloon

Interventions

GENOSS® DCB

Drug Coated Balloon

Intervention Type: DEVICE

SeQuent® Please NEO

Drug Coated Balloon

Intervention Type: DEVICE

Other Intervention Names

Paclitaxel Coated PTCA Balloon catheter; Paclitaxel Coated PTCA Balloon catheter

Eligibility Criteria

Inclusion Criteria

• Age ≥19 years old
• Patients requiring PCI with coronary de novo lesions
• Patients with stable angina pectoris, or unstable angina pectoris, and asymptomatic myocardial ischemia
• Women of childbearing age who agreed to use one or more of the clinically appropriate methods of contraception during the trial period.
• In case of voluntarily deciding to participate in this clinical trial by signing the informed consent form

• Patients with significant coronary artery stenosis (> 50% diameter stenosis on coronary angiography)
• On coronary angiography, the length of the lesion is less than 34 mm and the diameter of the reference vessel of the coronary artery is 2.0 - 4.0mm.

Exclusion Criteria

• Patients with ST-segment elevation myocardial infarction (STEMI)
• Patients who are contraindicated in aspirin, heparin, ticagrelor, iopromide, clopidogrel, prasugrel and paclitaxel
• Patients with platelet aggregation or disorders at risk of increased bleeding, such as gastrointestinal ulcers, which limit platelet aggregation inhibitory therapy and anticoagulant therapy
• Patients with a left ventricular ejection fraction of less than 30% on echocardiography
• Patients with renal insufficiency (eGFR<30mL/min)
• Patients with a history of cardiogenic shock
• Pregnant or lactating women
• The patients have a life expectancy of less than 12 months
• Patients who have or currently have medical conditions such as psychiatric disorders that significantly affect this clinical trial
• Patients who, in the investigator's judgment, may not be suitable for this clinical trial or may increase the risk associated with participation in the study
• Patients who are currently participating in other clinical trials or have experience participating in other clinical trials within 90 days from the screening date
• Patients who are unsuitable for the study according to the investigator judges

• Patients with left main coronary lesion
• Patients with graft vessel lesion
• Patients who cannot apply pre-dilation or fail in pre-dilation to apply medical devices for clinical trials
• Patients with one of the following items after pre-dilation of the target lesion

• When FFR (Functional measurement) is measured as ≤ 0.8 in large vessels with a reference vessel diameter exceeding 2.75mm (However, depending on the judgment of the investigator, FFR measurement may not be performed.)
• Patients who need stenting due to vascular dissection that restricts blood flow
• Residual stenosis > 30%
• TIMI flow < 3

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genoss Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eun-Seok Shin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology, Ulsan University Hospital

Locations

Ulsan University Hospital

Ulsan, , South Korea

Countries

South Korea

References

Shin ES, Park Y, Lee JY, Her AY, Chon MK, Kim S, Rha SW, Oh GC, Cho DK, Kim B, Bae JW. A Prospective Randomized Trial Comparing 2 Different Paclitaxel-Coated Balloons in De Novo Coronary Artery Disease. JACC Asia. 2025 Jan 7;5(1):15-24. doi: 10.1016/j.jacasi.2024.10.028. eCollection 2025 Jan.

Reference Type: DERIVED

PMID: 39886190 (View on PubMed)

Other Identifiers

CEP-DS1001_DN

Identifier Type: -

Identifier Source: org_study_id