Coronary Artery Disease
Conditions
Keywords
de novo lesions
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.
Interventions
DEVICEGENOSS® DCB
Drug Coated Balloon
DEVICESeQuent® Please NEO
Drug Coated Balloon
Sponsors
Genoss Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| in-lesion late lumen loss after percutaneous coronary intervention in patients with coronary de novo lesions | Follow-up angiography at 6 months after the procedure | late lumen loss between test group and control group evaluated by quantitative coronary analysis in patients with coronary de novo lesions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Restenosis rate after percutaneous coronary intervention in patients with coronary de novo lesions | Follow-up angiography at 6 months after procedure | Restenosis is defined as a case where the DS(Diameter stenosis) of the reference vessel diameter is 50% or more when the successfully treated lesion is evaluated through coronary angiography. |
| Target vessel failure(TVF) | at 6 and 12 months after the procedure | Composite of TVF(cardiac death, TV-MI, and ID-TVR) |
Countries
South Korea
Outcome results
None listed