The purpose of this study is to evaluate the efficacy and safety of sirolimus drug-eluting coronary balloon catheter in treatment of coronary bifurcation lesions. This is a prospective, multicenter, randomized controlled, non-inferior clinical trial, which would enroll 280 participants in total. Paticipants would undergoing PCI with sirolimus DEB or paclitaxel DEB, and be followed-up to 24 months.
The purpose of this study is to evaluate the efficacy and safety of sirolimus drug-eluting coronary balloon catheter in treatment of coronary bifurcation lesions. This is a prospective, multicenter, randomized controlled, non-inferior clinical trial, which would enroll 280 participants in total. Paticipants with would undergoing PCI with sirolimus DEB or paclitaxel DEB, and be followed-up to 24 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
280
Patients in experimental group will undergo PCI, using sirolimus drug-eluting coronary balloon catheter.Subjects without stent implantation were regularly treated with dual antiplatelet for 9 months after surgery. Subjects with stents were regularly treated with dual antiplatelet for 12 months after the surgery, in accordance with the applicable guidelines for percutaneous coronary intervention.
Patients in control group will undergo PCI, using paclitaxel drug-eluting coronary balloon catheter.Subjects without stent implantation were regularly treated with dual antiplatelet for 9 months after surgery. Subjects with stents were regularly treated with dual antiplatelet for 12 months after the surgery, in accordance with the applicable guidelines for percutaneous coronary intervention.
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGStenosis of lumen diameter of target lesion branch
The degree of lumen diameter stenosis (%) =(1- the minimum lumen diameter of the vessel/the reference diameter of the target lesion vessel)×100%
Time frame: 9 months (±30 days)
Success rate of interventional treatment
Including device success, pathological success and clinical success
Time frame: Index Procedure
Incidence of restenosis of target lesions
Restenosis defined as angiographic stenosis ≥50%
Time frame: 9 months (±30 days)
Late lumen loss (LLL)
Time frame: 9 months (±30 days)
Target lesions revascularization (TLR)
Including PCI re-stenting, balloon dilation, plaque grinding or excision, coronary artery bypass grafting (CABG)
Time frame: 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), 24 months (±30 days)
Target vessel revascularization (TVR)
Including PCI re-stenting, balloon dilation, plaque grinding or excision, coronary artery bypass grafting (CABG)
Time frame: 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), 24 months (±30 days)
Target lesion failure rate (TLF)
Including cardiac death, target vascular-associated myocardial infarction, and target lesion revascularization
Time frame: 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), 24 months (±30 days)
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