PIONEER-II OPC trial is a prospective, multicenter, single-arm registry trial. 1000 subjects from approximately 40 interventional cardiology centers will be enrolled to evaluate the target lesion failure(TLF) as the primary endpoint at 1 year. 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
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,000
Stent platform: cobalt-chromium alloy
Zhongshan Hospital
Shanghai, China
Target Lesion Failure
Target Lesion Failure(TLF) is defined as cardiac death, target vessel myocardial infarction(MI), or clinically-driven target lesion revascularization (TLR).
Time frame: 1 year
Stent implantation success rate
The stent implantation success rate includes device, lesion and clinical success rate.
Time frame: 5 years after PCI
Device-oriented Composite Endpoint(DoCE)
Device-oriented Composite Endpoint is defined as cardiac death, target vessel MI, or clinically-driven TLR (TLF).
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 MI, or any revascularization.
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.