Coronary Heart Disease Clinical Trial
Janus stent is the only marketed drug-eluting stent (DES) without polymer coating as yet in
China. The goal of this study is to evaluate the efficacy of JANUS (Tacrolimus eluted stent)
in inhibiting of restenosis in percutaneous coronary intervention (PCI) real world and to
observe the safety and efficacy of 4 months’clopidogrel treatment after implantation of
JANUS stent.
Patients were enrolled and randomized to be treated by JANUS or SRNCRO (bare metal stent
with the same platform as JANUS). All enrolled patients received daily clopidogrel for 4
months and aspirin for life long for post-PCI period(In AMI group, patients received daily
clopidogrel 150mg for 2 weeks at first). The primary endpoints included death of heart,
myocardial infarction, revascularization of the target lesson, sub-acute and late stent
thrombosis one year after PCI, The secondary endpoints included MACE at 30 days, 6 months
and restenosis by follow-up angiogram at 6 to 12 months.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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