PIONEER-II RCT trial is a prospective, multicenter, randomized, non-inferiority registry trial. 539 subjects from about 40 interventional cardiology centers in China will be enrolled to evaluate In-stent late lumen loss(LLL) as the primary endpoint at 9 months. And all the subjects will be followed up to 5 years to attain the data of the secondary endpoints.
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
539
Stent platform: cobalt-chromium alloy
Stent platform: stainless steel
Zhongshan Hospital
Shanghai, China
in-stent Late Lumen Loss, 9M
The primary endpoint is in-stent Late Lumen Loss (LLL) at 9-month after stent implantation as assessed by off-line quantitative coronary angiography (QCA).
Time frame: QCA at 9-month follow-up window
Stent implantation success rate
The stent implantation success rate includes device success, lesion success and clinical success.
Time frame: 5 years after PCI
Binary restenosis rate
Binary restenosis was defined in every segment (proximal, distal, and stent) as a \>50% diameter.
Time frame: 9 months
in-segment LLL
to evaluate the in-sigment Late Lumen Loss (LLL) at 9-month after stent implantation as assessed by off-line quantitative coronary angiography (QCA).
Time frame: 9 months
diameter stenosis degree
to compare the lumen diameter at 9-month after stent implantation with the baseline diameter as assessed by off-line quantitative coronary angiography (QCA).
Time frame: 9 months
Device-oriented Composite Endpoint (DoCE)
Device-oriented Composite Endpoint is defined as cardiac death, target vessel MI, or clinically-driven target lesion revascularization (TLR).
Time frame: 1, 6, 12 month, and annually up to 5 years post procedure
Patient-oriented Composite Endpoint (PoCE)
Patient-oriented Composite Endpoint is defined as all cause death, all myocardial ischemia (MI), or any revascularization.
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Time frame: 1, 6, 12 month, and annually up to 5 years post procedure
Academic Research Consortium(ARC) defined stent thrombosis
Definite and probable stent thrombosis during acute, subacute, later and very late phase.
Time frame: 5 years after PCI