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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
230
a Sirolimus Coated Balloon Catheter designed and produced by Acotec
a Paclitaxel Coated Balloon Catheter(trade name:Bingo)
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGDiameter 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.
Time frame: 9 months post procedure
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.
Time frame: Immediately after procedure
Rate of lesion success
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.
Time frame: 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) .
Time frame: 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.
Time frame: 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.
Time frame: 30 days, 6 months, 9 months, 12 months post procedure
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Diameter stenosis rate
Defined as the rate of restenosis (\>50% diameter stenosis) of main vessel after 9 months at 9 months post procedure.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months post procedure