Phase
Condition
Coronary Artery Disease
Cardiac Disease
Vascular Diseases
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
General Inclusion Criteria:
Age ≥ 18 years;
Subjects (or legal guardians) understand the testing requirements and procedures, andprovide written informed consent;
Subjects could undergo percutaneous coronary intervention (PCI);
Subjects have symptomatic coronary artery disease or have confirmed asymptomaticischemia;
Subjects are eligible candidates for coronary artery bypass graft surgery (CABG);
Left ventricular ejection fraction (LVEF) within 60 days ≥ 30%;
Subjects were willing to accept the trial plan calls for all subsequent evaluations;
Subjects can endure 6 months dual anti-platelet therapy, and met one or more criteriaas the following:
1.Age ≥ 75years; 2.Subjects with hemoglobin<10g/dL, or subjects received transfusiontherapy 4 weeks ago; 3.Subjects with renal insufficiency (eGFR < 60 ml / min); 4.Subjects with HAS-BLED score ≥3.0; 5.Femal patients with acute cononary syndrome; 6.BMI < 18.5 Kg/M2; 7.Subjects with congestive heart failure and with LVEF30%-50%; 8.Subjects had a history of hospitalization due to bleeding; 9.Subjects withthrombocytopenia (platelet < 100,000 / mm3); 10.Subjects had a histroy of intracranialhemorrhage; 11.Subjects had a histroy of intracranial ischemia stroke in 6 months; 12.Subjects plan to receive non-steroidal anti-inflammatory or steroid treatment formore than 30 days after the baseline PCI; 14.Subjects were expected to receiveadditional treatment after PCI and cannot undergo long-term DAPT therapy; 15.Subjectshad a history of stomach ulcers or active ulcers. Angiographic Inclusion Criteria
Target lesions must be new and have a visually estimated reference diameter ≥2.25 mmand ≤4.0 mm in autologous coronary artery;
Target lesions must be moderate-severe calcification;
No limitations in target lesion length and number, and the number of implanted stentsis less than 4;
ALL target lesion must be able to successfully expand and implant Firehawk™ stent.
Exclusion
Clinical Exclusion Criteria:
- Subjects recently suffer from MI (within 4 week) and ECG changes/clinical symptomsconsistent with AMI, or accompanied with increased cardiac biomarkers (CK-MB, CK, TNTor TNI) and at least one of the following :
CK-MB> 3ULN, regardless of the value of total CK;
If CK-MB or CK was not detected, but cTN> 1ULN, and at least one of thefollowing:
Ischemic symptoms and ECG changes of new ischemia;
Development of pathologic Q waves in the ECG;
Imaging evidence of new loss of viable myocardium or new regional wallmotion abnormality.
Subject had Re-MI before randomized;
Subject with hemodynamic instability (Killip class IV);
Subjects were detected ventricular aneurysm greater than 3.0*2.0cm or intraventricularthrombosis by cardiac ultrasonography in 30 days;
Subjects with Life-threatening arrhythmias;
Subjects were expected to receive oral anticoagulation therapy after the baseline PCI;
Subjects cannot endure dual anti-platelet therapy for 1 month;
Subjects with mechanical complications after myocardial infarction;
Subjects had an organ transplant or are waiting for an organ transplant;
Subjects are receiving chemotherapy or will receive a chemotherapy within 30 daysafter PCI;
Subjects with abnormal counts of white blood cell (WBC);
Subjects with verified or suspected acute liver disease, including lab results ofacute liver disease;
Subjects had permanent neurological diseases in the past 6 months;
Subjects had any PCI (such as balloon angioplasty, stent, cutting balloon) treatmentin target vessels within 12 months prior to baseline;
Non-target vessel had been implanted non-research stent 5 months ago before thebaselin PCI.
Subjects plan to undergo PCI or CABG within 1 year after the baseline PCI;
Subjects have any coronary endovascular brachytherapy treatment previously;
Subjects associated with drugs allergy (such as sirolimus, or structure-relatedcompounds fluorinated polymers, thiophenepyridine or aspirin);
Subjects are suffering from other serious illness (such as cancer, congestive heartfailure), which may cause drop in life expectancy to less than 12 months;
Subjects are currently abusing drugs (such as alcohol, cocaine, heroin, etc);
Subject plan to undergo any operations that may lead to confuse with the programme;
Subjects were participating in another study of drug or medical device which did notmeet its primary endpoint;
Subjects plan to pregnant within 12 months after baseline;
Subjects are pregnant or breastfeeding women. Angiographic Exclusion Criteria (visual estimate):
Target lesions with the following criteria: left main, saphenous vein grafts orarterial grafts, via saphenous vein grafts or arterial graft, more than 4 stents havebeen implanted and in-stent sestenosis;
Subjects with unprotected left main coronary artery disease (diameter stenosis >50%);
Subjects have a protected left main coronary artery disease (diameter stenosis> 50%and left coronary artery bypass surgery), as well as target lesions located in the LADand LCX;
Subjects with other lesions of clinical significance, may be need intervention within 12 months after baseline.
Study Design
Study Description
Connect with a study center
The General Hospital of Shenyang Military
Shenyang, Liaoning
ChinaActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.