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

Genoss

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Device: SeQuent® Please NEO

Device: GENOSS® DCB

Study type

Interventional

Funder types

Industry

Identifiers

NCT05096442

CEP-DS1001_DN

Details and patient eligibility

About

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).

Full 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.

Enrollment

204 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Inclusion criteria for coronary angiography

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

Exclusion criteria for coronary angiography

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