This study is designed to investigate whether IVUS-guided DK crush stenting technique compared to angiography-guided DK crush after the indexed procedure will lead to lower rates of the composite endpoint of target vessel failure (TVF) at 12 months. The individual components of TVF include cardiac death, target-vessel myocardial infarction (MI), or target vessel revascularization (TVR). Complex bifurcation lesions were defined according to DEFINITION study.
This is a prospective, multi-center, randomized-controlled, single blind, superiority trial that will include 35 international sites. The investigators aim to enroll 556 subjects with complex coronary bifurcation lesions in native coronary arterial segments. All patients with complex coronary bifurcation lesions suitable for DES implantation will undergo 1:1 randomization either to IVUS-guided or angiography-guided DK crush stenting using a randomization schedule blocked by site. All subjects will be screened according to the predefined inclusion and exclusion criteria per protocol and will further undergo angiography before DES implantation. Data and images will be collected during the index procedure, during re-intervention in the case of clinically driven TVF, and at the predefined 12-month clinical follow-up visit. All subjects will also undergo angiographic follow-up at 13 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
556
DK crush technique with SYNERGY (Boston Scientific) drug-eluting stent implantation.
Nanjing First Hospital
Nanjing, Jiangsu, China
Rate of target vessel failure
TVF defined as the composite of cardiac death, target vessel myocardial infarction (TVMI), and clinically driven TVR.
Time frame: 12 months after DES implantation
Rate of stent thrombosis
The safety endpoint was stent thrombosis (ST), according to the definition by Academic Research Consortium.
Time frame: 12 months after DES implantation
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