The purpose of this study is to evaluate the safety and effectiveness of Genoss® DCB by demonstrating non-inferiority in patients with in-stent restenosis (ISR) compared with a product of the same category (Sequent® Please NEO). The experimental group was treated with Genoss® DCB, and the control group was treated with SeQuent® Please NEO. In this study, the end point of 9 months after procedure was used as the main endpoint to evaluate the effectiveness of Paclitaxel coated PTCA balloon catheter. The safety of the catheter was evaluated by cardiovascular adverse events.
In a randomized controlled trials to compare with the same-category medical device (Sequent® Please NEO), 224 patients with in-stent restenosis (ISR) were recruited from a total of 13 institutions, and the enrolled subjects were 1: 1 through randomization. The ratio was assigned to the test group(Genoss® DCB) and the control group(SeQuent® Please NEO), and each of the test or control devices was assigned to receive the procedure. All patients were followed up 30 days, 6 months, 9 months, 1 year and 2 years after procedure, and angiographic follow-up was performed 9 months after procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
224
Drug Coated Balloon
Drug Coated Balloon
Department of Cardiology, First Affiliated Hospital of Air Force Medical University of Chinese PLA
Xi'an, Shaanxi, China
In-segment late lumen loss after procedure
In-segment late lumen loss between test group(Genoss DCB) and control group(Sequent Please) evaluated by quantitiative coronary analysis in patients with ISR
Time frame: at 9 months after procedure
Device-oriented compoiste endpoint (DOCE)
DOCE is defined as a composite of cadiac death, target vessel-related myocardial infarction (TV-MI), and ischemia-driven target lesion revascularization (ID-TLR)
Time frame: at 30 days, 6 months, 9 months, 12 months and 24 months after procedure
Patient-oriented composite endpoint (POCE)
POCE is defined as a composite of all-cause death, any myocardial infarction, any revascularization
Time frame: at 30 days, 6 months, 9 months, 12 months, and 24 months after procedure
Stent thrombosis by ARC definition
Time frame: at 6 months, 9 months, 12 months, 24 months after procedure
Retenosis rate
Time frame: at 9 months after procedure
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