The purpose of this study is to establish the optimal strategy for stenting in coronary bifurcation lesion.
The current study is designed as a multicenter, randomized and prospective study aiming to compare the effect of two-stenting and simple stenting techniques in patients with complex bifurcation lesions. Based on the previous studies, the rate of 1-year target lesion failure events was around 14% after PCI with provisional stenting. And our previous data showed that this event at 12-month after two-stenting procedure was 7%. Considering the lost to follow-up, it is anticipated that up to 660 patients will be enrolled in the trial. All patients will have repeat angiography at 13 months, with clinical follow-up to 5 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
660
Nanjing First Hospital
Nanjing, Jiangsu, China
Target lesion failure
Combined end point of: cardiac death, target-vessel myocardial infarction (MI), or target lesion revascularization (TLR).
Time frame: 12 months
Cardiac death
Time frame: 12 months
Target-vessel myocardial infarction
Time frame: 12 months
Target lesion revascularisation
Time frame: 12 months
Target vessel revascularisation
Time frame: 12 months
Stent thrombosis
Time frame: 12 months
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