This study is designed to investigate whether drug-coated balloon (DCB) compared to conventional balloon angioplasty for side branch after provisional stenting will lead to lower rates of the composite endpoint of major adverse cardiac event (MACE) at 12 months. The individual components of MACE include cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR). True bifurcation lesions were defined according to Medina classification.
This is a prospective, multi-center, randomized-controlled, single blind, superiority trial that will include 25 international sites. The investigators aim to enroll 784 subjects with true coronary bifurcation lesions in native coronary arterial segments. All patients with true coronary bifurcation lesions suitable for angioplasty will undergo 1:1 randomization either to PS (provisional stenting)-DCB or PS-NCB (noncompliant balloon) group 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 after successful stenting of the main vessel with ostium side branch visually estimated stenosis ≥70%. Data and images will be collected during the index procedure, during re-intervention in the case of clinically driven revascularization, 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
784
Provisional stenting technique with DCB
Nanjing First Hospital
Nanjing, Jiangsu, China
Rate of major adverse cardiac event
MACE defined as the composite of cardiac death, myocardial infarction (MI), and clinically driven TLR.
Time frame: 12 months after angioplasty
Rate of all-cause death or cardiac death
In general, all deaths are considered cardiac unless an alternate cause is unequivocally established, even among subjects with serious noncardiac comorbidities.
Time frame: 12 months after angioplasty
Rate of periprocedural MI, Spontaneous MI, or target vessel MI
According to the DCB-BIF trial definition.
Time frame: 12 months after angioplasty
Rate of clinically-driven TLR or TVR
Clinically driven revascularization includes repeat PCI or coronary artery bypass graft (CABG) for recurrent or persistent symptomatic ischemia and can be defined according to the relationship to the index PCI (target lesion).
Time frame: 12 months after angioplasty
Rate of thrombosis
The safety endpoint was stent thrombosis (ST), according to the definition by Academic Research Consortium.
Time frame: 12 months after angioplasty
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