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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DIOR group | Experimental | in this group, patients will be treated with Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR) |
|
| Bingo group | Active Comparator | in this group, patients will be treated with Paclitaxel-Eluting Balloon (Bingo) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR) | Device | patients in the study group will be treated by the Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR) |
| Measure | Description | Time Frame |
|---|---|---|
| late lumen loss | in balloon dilated coverage area of the side branch lesion measured by QCA (Quantitative Coronary Angiography) | 9 months after operation |
| Measure | Description | Time Frame |
|---|---|---|
| device success | 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 | immediately post procedure |
| clinical success |
| Measure | Description | Time Frame |
|---|---|---|
| angiographic endpoints-late loss of side branch | assess in millimeter | 9 months after operation |
| angiographic endpoints-minimal lumen diameter (MLD) of side branch | assess in millimeter |
Inclusion Criteria:
Subjects that participate in this study must fulfill all the following criteria:
General inclusion criteria:
Angiographic inclusion criteria:
Exclusion Criteria:
If subjects fulfill any of below criteria, this subject shall be exclude from this study.
General exclusion criteria:
Angiographic exclusion criteria
1) Residual stenosis (DS %) is ≤50% (visually); 2) TIMI Grade-3 flow ((visually); 3) No angiographic complications (e.g., no-reflow, distal embolization, side branch closure) 4) No dissections NHLBI grade C-F;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bing Wang, professor | Contact | 86-024-28851120 | wangbindl@hotmail.com | |
| Geng Wang, professor | Contact | 86-024-28851120 | wanggeng69@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yaling Han, professor | The General Hospital of Northern Theater Command | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daqing Oil General Hospital | Daqing | Heilongjiang | China |
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| Paclitaxel-Eluting Balloon (Bingo) | Device | patients in the study group will be treated by the Paclitaxel-Eluting Balloon (Bingo) |
|
define as absence of patients oriented composite endpoints (PoCE) during hospitalization, based on the device success. |
| 1 month after operation |
| device oriented composite endpoints (DoCE) | that is TLF, define as the composite endpoint include cardiac death, target vessel myocardial infarction and ischemic driven target lesion revascularization (ID-TLR) | 1, 6, 9, 12 month after operation |
| patients oriented composite endpoints (PoCE) | define as a composite endpoints of all cause death, any myocardial infarction and any revascularization | 1, 6, 9, 12 month after operation |
| all cause death | include cardiac death, vascular death, noncardiovascular death | 1, 6, 9, 12 month after operation |
| myocardial infarction (MI) | target vessel MI, non-target vessel MI | 1, 6, 9, 12 month after operation |
| target lesion revasculation | ischemic driven, non-ischemic driven | 1, 6, 9, 12 month after operation |
| target vessel revasculation | ischemic driven, non-ischemic driven | 1, 6, 9, 12 month after operation |
| any coronary revasculation | 1, 6, 9, 12 month after operation |
| thrombosis in the side branch lesion | 1, 6, 9, 12 month after operation |
| 9 months after operation |
| angiographic endpoints-diameter stenosis (DS) | assess in percentage | 9 months after operation |
| angiographic endpoints-angiographic binary restenosis (ABR) | assess in percentage | 9 months after operation |
| Wuhan Asian Heart Hospital | Wuhan | Hubei | China |
|
| Nanjing First Hospital | Nanjing | Jiangsu | China |
|
| First Bethune Hospital of Jilin University | Changchun | Jilin | China |
| The Second Hospital of Dalian University | Dalian | Liaoning | China |
| General Hospital of Northern Theater Command | Shengyang | Liaoning | China |
|
| The First Hospital of China Medical University | Shengyang | Liaoning | China |
|
| First Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | China |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
|
| The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
|
| Beijing Anzhen Hospital Capital Medical University | Beijing | China |
| Shanghai East Hospital, | Shanghai | China |
|
| Tianjin Chest Hospital | Tianjin | China |
|
| ID | Term |
|---|---|
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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