Clinical Drug Experience Knowledgebase

Criteria

General Inclusion Criteria:

Age ≥ 18 years;
Subjects (or legal guardians) understand the testing requirements and procedures, and provide written informed consent;
Subjects with symptomatic coronary artery disease or confirmed asymptomatic ischemia;
Target lesion should be new lesion with visually estimated reference diameter ≥2.5 mm and ≤4.0 mm in autologous coronary artery;
Subjects willing to accept PCI therapy and to implant Firehawk™ stent only;
Left ventricular ejection fraction (LVEF) ≥ 30%;
Subjects willing to accept the trial plan calls for all subsequent evaluations.

Angiographic Inclusion Criteria:

Target lesions must be new and have a visually estimated reference diameter ≥2.5 mm and ≤4.0 mm in autologous coronary artery;
No limitations in target lesion length and number;
The first target lesion must be able to successfully expand and implant Firehawk™ stent.

Clinical Exclusion Criteria:

Subjects with ST-segment elevation myocardial infarction:
Subjects having an organ transplant or waiting for an organ transplant
Subjects receiving chemotherapy or going to receive a chemotherapy within 30 days after PCI
Subjects undergoing chronic (over 72 hours) anticoagulant therapy (such as heparin and coumarin) other than acute coronary syndrome
Subjects with abnormal counts of platelet and white blood cell (WBC) (investigator assess clinical significance combine normal reference range of laboratory)
Subjects with confirmed or suspected liver disease, including hepatitis lab results
Subjects with elevated serum creatinine level >3.0mg/dL or undergoing dialysis therapy
Subjects with active peptic ulcer, active gastrointestinal (GI) bleeding or other bleeding diathesis or coagulopathy, or refused a blood transfusion
Subjects with cerebral vascular accident (CVA) or transient ischemic attack (TIA) in the past 6 months, or with permanent nerve defects
Subjects undergoing any PCI treatment in target vessels within 12 months prior to baseline
Subjects planned to undergo PCI or CABG within 18 months after the baseline PCI
Subjects with a history of any coronary endovascular brachytherapy treatment previously
Subjects associated with drugs allergy (such as sirolimus, or structure-related compounds fluorinated polymers, thienopyridine or aspirin)
Subjects being suffered from other serious illness (such as cancer, congestive heart failure), which may cause drop in life expectancy to less than 18 months
Subjects with a history of drug abuse (such as alcohol, cocaine, heroin, etc.)
Subject planned to undergo any operations that may lead to confuse with the programme
Subjects participating in another study of drug or medical device which did not meet its primary endpoint
Subjects planned to pregnant within 18 months after baseline
Pregnant or breastfeeding women

Angiographic Exclusion Criteria:

Target lesions with the following criteria: left main, saphenous vein grafts or arterial grafts, via saphenous vein grafts or arterial graft, and in-stent restenosis;
Subjects with unprotected left main coronary artery disease (diameter stenosis >50%);
Protected left main coronary artery disease(diameter stenosis >50% and undergoing CABG)with target lesions located in left anterior descending artery and left circumflex artery;
Additional lesions of clinical significance possibly needing interventional within 18 months after enrollment..