Percutaneous Coronary Intervention
Conditions
Keywords
coronary artery stenosis, drug eluting balloon, bifurcation
Brief summary
To evaluate the safety and effectiveness of paclitaxel-eluting coronary artery balloon dilation catheter (DIOR) in revascularization of coronary bifurcation lesions compared with paclitaxel-eluting balloon (Bingo), and to provide the clinical data for the formal application in China and for the approvement of China marketing.
Detailed description
This is a prospective, multicenter, randomize, control and non-inferior study. 220 patients with bifurcation lesions will be randomized 1:1 to each group. after the main branch has been treated successfully, and if the side branch's stenosis is more than 70% and can be pre-dilated by POBA (plain old balloon angioplasty) successfully, then randomizing. the patients in the study group will be treated with paclitaxel-eluting coronary artery balloon dilatation catheter (DIOR), while those in the control group will be treated with paclitaxel-eluting balloon (Bingo). Clinical follow-up will be conducted at baseline, operation, hospital discharge, 1 month, 6 months, 9 months and 12 months after operation, and angiographic follow-up will be conducted at 9 months. The primary endpoint is late lumen loss (LLL) in the balloon dilatation coverage area of side branch of at 9 month after operation. The secondary endpoints include device success, clinical success, target lesion failure (TLF), target lesion revascularization (TLR), clinical composite endpoints and imaging endpoints. The information of adverse events, serious adverse events and device defects will be collected during the study.
Interventions
DEVICEPaclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR)
patients in the study group will be treated by the Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR)
DEVICEPaclitaxel-Eluting Balloon (Bingo)
patients in the study group will be treated by the Paclitaxel-Eluting Balloon (Bingo)
Sponsors
CCRF Inc., Beijing, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Subjects that participate in this study must fulfill all the following criteria: General inclusion criteria: 1. Age from 18 to 80 years old, man or non-pregnant woman; 2. Subjects with stable or unstable angina, old myocardial infarction, or asymptomatic ischemic evidence with clinical diagnosis; 3. Subjects without contraindications of coronary artery bypass grafting (CABG); 4. Subjects must agree to the follow up of angiographic and clinical required in the study; 5. Subjects are able to understand the purpose of this study, provide an informed consent to show recognize to the study protocol. Angiographic inclusion criteria: 1. One or two bifurcation lesions, locate in different epicardial vessels, the bifurcation lesion in each epicardial vessel can not over 1; or 1 de nove coronary artery bifurcation can be included after 1 lesion of non-target vessel has been successfully treated by PCI (Percutaneous Coronary Intervention); 2. Residual diameter stenosis in main branch (MB) ≥ 70% (visually), or ≥ 50% simultaneously with clinical symptom, and the diameter stenosis in side branch (SB) ≥ 50% (visually); and the main branch's residual stenosis ≤ 20% with TIMI 3 flow post the stent placement, while the side branch diameter stenosis ≥ 70% post the MB stenting; 3. Fulfill the definition of truly bifurcation lesions by Medina type (1.1.1、1.0.1、0.1.1); 4. Diameter in side branch between ≥ 2.5 mm to ≤ 4.00 mm (visually) and lesion length ≤ 26 mm (visually); 5. Each side branch of the bifurcation lesion can be treated by only 1 study drug coated balloon (DCB) or control DCB, and the lesion shall be fully covered by the DCB ( the distal end of the balloon shall exceed the lesion at least 1 mm).
Exclusion criteria
If subjects fulfill any of below criteria, this subject shall be exclude from this study. General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| late lumen loss | 9 months after operation | in balloon dilated coverage area of the side branch lesion measured by QCA (Quantitative Coronary Angiography) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| patients oriented composite endpoints (PoCE) | 1, 6, 9, 12 month after operation | define as a composite endpoints of all cause death, any myocardial infarction and any revascularization |
| target lesion revasculation | 1, 6, 9, 12 month after operation | ischemic driven, non-ischemic driven |
| target vessel revasculation | 1, 6, 9, 12 month after operation | ischemic driven, non-ischemic driven |
| any coronary revasculation | 1, 6, 9, 12 month after operation | — |
| thrombosis in the side branch lesion | 1, 6, 9, 12 month after operation | — |
| device success | immediately post procedure | define as dilation success in the side branch lesion by study balloon or control ballon, that is the residual stenosis ≤50%，TIMI (Thrombolysis In Myocardial Infarction) 3 flow and without type C or above dissection |
| clinical success | 1 month after operation | define as absence of patients oriented composite endpoints (PoCE) during hospitalization, based on the device success. |
| device oriented composite endpoints (DoCE) | 1, 6, 9, 12 month after operation | that is TLF, define as the composite endpoint include cardiac death, target vessel myocardial infarction and ischemic driven target lesion revascularization (ID-TLR) |
| all cause death | 1, 6, 9, 12 month after operation | include cardiac death, vascular death, noncardiovascular death |
| myocardial infarction (MI) | 1, 6, 9, 12 month after operation | target vessel MI, non-target vessel MI |
Other
| Measure | Time frame | Description |
|---|---|---|
| angiographic endpoints-diameter stenosis (DS) | 9 months after operation | assess in percentage |
| angiographic endpoints-angiographic binary restenosis (ABR) | 9 months after operation | assess in percentage |
| angiographic endpoints-minimal lumen diameter (MLD) of side branch | 9 months after operation | assess in millimeter |
| angiographic endpoints-late loss of side branch | 9 months after operation | assess in millimeter |
Countries
China
Contacts
Primary ContactBing Wang, professor
Backup ContactGeng Wang, professor
Outcome results
None listed