Coronary Artery Disease
Conditions
Keywords
In-Stent Restenosis
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPaclitaxel Coated PTCA Balloon Catheter(Genoss® DCB)
Drug Coated Balloon
Drug Coated Balloon
Sponsors
Genoss Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Subject related inclusion criteria * Age≥18 years old & ≤80 years old. * Patients with stable angina pectoris, unstable angina pectoris, stable acute myocardial infarction or confirmed silent myocardial ischemia. * Patients who can understand the purpose of the study and voluntarily participate in and sign informed consent. * It is suitable for patients undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). Desease related inclusion criteria * The target lesions were in stent restenosis: Mehran type I, II and III stenosis. * The stenosis rate of target lesion diameter was more than 70%, or more than 50%, accompanied by objective evidence of ischemia (such as stress electrocardiogram, myocardial perfusion imaging, FFR, etc.) * The reference vessel diameter of the target lesion was 2.0-4.0 mm, and the target lesion length was less than or equal to 26 mm. * It is expected that no more than two drug balloons will be used in each subject, and each target lesion can be covered by one drug balloon. * At most 2 primary lesions need interventional treatment, and the distance from the target lesion is more than or equal to 10 mm, and can be successfully treated before the intervention of the target lesion.
Exclusion criteria
Subject related
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-segment late lumen loss after procedure | at 9 months 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device-oriented compoiste endpoint (DOCE) | at 30 days, 6 months, 9 months, 12 months and 24 months after procedure | DOCE is defined as a composite of cadiac death, target vessel-related myocardial infarction (TV-MI), and ischemia-driven target lesion revascularization (ID-TLR) |
| Patient-oriented composite endpoint (POCE) | at 30 days, 6 months, 9 months, 12 months, and 24 months after procedure | POCE is defined as a composite of all-cause death, any myocardial infarction, any revascularization |
| Stent thrombosis by ARC definition | at 6 months, 9 months, 12 months, 24 months after procedure | — |
| Retenosis rate | at 9 months after procedure | — |
Countries
China
Outcome results
None listed