The purpose of this study is to evaluate new generation drug eluting stent (DES) of MicroPort of its safety, efficacy and delivery system in treating CAD.
The primary endpoint is in-stent late lumen loss after 9 months of the stent implantation. The secondary endpoint is in-stent percent diameter stenosis.This study is based on non-inferior assumption (vs. Xience V), requiring both endpoints reach statistical significance. Prespecified OCT follow-up is planned at 3-Year after index procedure at 3 chosen hospitals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
458
Fuwai Hospital
Beijing, China
9 Months In-stent Late Lumen Loss
To observe in-stent late lumen loss after 9 months of stent implantation It means the difference between the minimal lumen diameter immediately after stent implantation and the minimal lumen diameter by angiography review 9 months after the procedure
Time frame: 9 months
9 Months In-stent Diameter Stenosis
the in-stent diameter stenosis 9 months post-procedure
Time frame: 9 months
Target Lesion Failure(TLF) Rate
Percentage of participants with the determination of TLF. TLF is the composite of sudden cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).
Time frame: 1 years after index PCI
TLF(Target Lumen Failure) Rate
percentage of participants with the determination of TLF, TLF include target vessel myocardial infarction, symptom-driven target lesion revascularization and sudden cardiac death.
Time frame: 3 years after index PCI (Percutaneous Coronary Intervention)
TLF(Target Lumen Failure)
percentage of participants with the determination of TLF, TLF include target vessel myocardial infarction, symptom-driven target lesion revascularization and sudden cardiac death.
Time frame: 5 years after index PCI
Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)
Time frame: 1 years after index PCI
Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)
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Time frame: 3 years after index PCI
Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)
Time frame: 5 years after index PCI