The purpose of this study is to evalute the clinical safety and effectiveness of released specification (2.25mm) of FirehawkTM Sirolimus target-eluting coronary stent system.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Implantation of the released specification (2.25mm) of FirehawkTM rapamycin target-eluting coronary stent systems
Fu Wai Hospital
Beijing, Beijing Municipality, China
In-stent Late Loss
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 month after stent implantation
Number of Participants With Target Lesion Failure
including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization
Time frame: 12 months
Number of Participants With Target Lesion Failure
including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization
Time frame: 2 years
Number of Participants With Target Lesion Failure
including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization
Time frame: 3 years
Number of Participants With Target Lesion Failure
including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization
Time frame: 4 years
Number of Participants With MACE
a composite endpoint of all cause death, any myocardial infarction and any revascularization
Time frame: 12 months
Number of Participants With MACE
a composite endpoint of all cause death, any myocardial infarction and any revascularization
Time frame: 2 years
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Number of Participants With MACE
a composite endpoint of all cause death, any myocardial infarction and any revascularization
Time frame: 3 years
Number of Participants With MACE
a composite endpoint of all cause death, any myocardial infarction and any revascularization
Time frame: 4 years