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| Name | Class |
|---|---|
| Shanghai Zhongshan Hospital | OTHER |
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The aim of this randomized controlled trial is to examine the treatment of coronary bifurcation lesion with a sirolimus coated balloon versus a paclitaxel coated balloon. This trial is designed as prospective, multicenter, randomized and open-label.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | a Sirolimus Coated Balloon |
|
| Control Group | Active Comparator | a Paclitaxel Coated Balloon Catheter |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sirolimus Coated Balloon Catheter | Device | a Sirolimus Coated Balloon Catheter designed and produced by Acotec |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diameter stenosis rate of bifurcation lesion determinated by Digital Substraction Angiography (DSA) at 9 months post procedure. | Defined as (1-minimum lumen diameter of target lesion/reference vessel diameter)*100% at 9 months post procedure. | 9 months post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of device success | Defined as the rate of successful delivery and withdrawal of the delivery catheter, and achieving a final in-lesion residual stenosis less than 30% and TIMI flow grade 3 by using the assigned device only. | Immediately after procedure |
| Rate of lesion success |
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Inclusion Criteria:
Exclusion Criteria:
Angiographic Inclusion Criteria:
Angiographic Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lu Hao | Contact | 021-64041990 | lu.hao.@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ge Junbo | Shanghai Zhongshan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | China |
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| a Paclitaxel Coated Balloon Catheter | Device | a Paclitaxel Coated Balloon Catheter(trade name:Bingo) |
|
Defined as the rate of achieving a final in-lesion residual stenosis < 30% by visual estimate and TIMI flow grade 3 by using any percutaneous method. |
| Immediately after procedure |
| Rate of procedure success | Defined as the rate of achieving lesion success without MACE (composite of cardiac death, MI and TLR events) . | Immediately after procedure |
| Rate of target lesion failure (TLF) or device-related composite endpoints (DoCE) | Defined as a composite rate of cardiac death, target vessel-related MI, or ischemia-driven TLR events at 30 days, 6 months, 9 months and 12 months post procedure. | 30 days, 6 months, 9 months, 12 months post procedure |
| Rate of patient-related composite endpoints (PoCE) | Defined as a composite rate of all cause death, all cause-related MI or TLR events at 30 days, 6 months, 9 months and 12 months post procedure. | 30 days, 6 months, 9 months, 12 months post procedure |
| Diameter stenosis rate | Defined as the rate of restenosis (>50% diameter stenosis) of main vessel after 9 months at 9 months post procedure. | 9 months post procedure |
| Late lumen loss (LLL) | Defined as the difference of minimum lumen diameter (MLD) from post procedure to 9 months follow-up, including late lumen loss of main vessel and side branch. | 9 months post procedure |
| Angiographic binary restenosis (ABR) rate | Defined as the percentage rate of binary restenosis determined by angiographic at 9 months post procedure. | 9 months post procedure |
| Rate of composite safety endpoint | Defined as a composite rate of all-cause death, cardiogenic death, myocardial infarction, target vessel-related myocardial infarction, incidence of thrombotic events (acute, subacute, late) defined by ARC at 12 months post procedure. | 12 months post procedure |