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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
204
Drug Coated Balloon
Drug Coated Balloon
Ulsan University Hospital
Ulsan, South Korea
in-lesion late lumen loss after percutaneous coronary intervention in patients with coronary de novo lesions
late lumen loss between test group and control group evaluated by quantitative coronary analysis in patients with coronary de novo lesions
Time frame: Follow-up angiography at 6 months after the procedure
Restenosis rate after percutaneous coronary intervention in patients with coronary de novo lesions
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.
Time frame: Follow-up angiography at 6 months after procedure
Target vessel failure(TVF)
Composite of TVF(cardiac death, TV-MI, and ID-TVR)
Time frame: at 6 and 12 months after the procedure
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