Fu Wai Hospital
Beijing, Beijing Municipality, 100037, China
NCT Number: NCT02688868
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100037, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Implantation of the released specification (2.25mm) of FirehawkTM rapamycin target-eluting coronary stent systems
Time frame: 9 month after stent implantation
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: 12 months
including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization
Time frame: 2 years
including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization
Time frame: 3 years
including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization
Time frame: 4 years
including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization
Time frame: 12 months
a composite endpoint of all cause death, any myocardial infarction and any revascularization
Time frame: 2 years
a composite endpoint of all cause death, any myocardial infarction and any revascularization
Time frame: 3 years
a composite endpoint of all cause death, any myocardial infarction and any revascularization
Time frame: 4 years
a composite endpoint of all cause death, any myocardial infarction and any revascularization
Shanghai MicroPort Medical (Group) Co., Ltd.
Industry
The Safety and Effectiveness Evaluation of New Specifications (2.25mm) of FirehawkTM Sirolimus Target-eluting Coronary Stent System in the Treatment of Coronary Heart Disease: a Prospective, Multicenter, Single-group Study.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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