Coronary Artery Disease
Conditions
Interventions
experimental group:Implant BIOMAGIC BVS
Control group:Implant Boston Scientific's Promus PREMIER stent
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: General inclusion criteria 1. Aged 18-75 years, male or non-pregnancy female; 2. Patients with the indications of coronary artery bypass surgery (CABG); 3. Patients who understand the study objectives, participate in the trial and sign the informed consent form(ICF) voluntarily, agree to be followed up. QCA inclusion crtiteria 1. One or two primary target lesions: (1) Only has one target lesion; (2) If has two target lesion, they must be in different epicardial coronary blood vessels, and all be in conformity with the Inclusion/Exclusion Criteria; (3) Epicardial coronary blood vessels include left anterior descending artery (LAD) and its branches, left cyclic branch arteries (LCX) and their branches, and right coronary artery (RCA) and its branches. So, for examples, the patients could NOT have two lesions which are all in LAD and its branches. 2. Diameter stenosis rate >= 70% (or >= 50% and the same scope has clinical evidence of myocardial ischemia), blood TIMI >= 1 level; 3. Target lesion length must be = 2.5 mm and <= 3.75 mm, and each target lesion can be covered by one stent.
Exclusion criteria
Exclusion criteria: General exlusion criterion 1. Acute myocardial infarction (AMI) in 1 week OR myocardial enzymes has NOT returned to normal after MI; 2. The target vessel has been implanted any stent in 1 year, OR is going to have PCI in half of year, OR non-target vessel has haven PCI in 30 days before the surgery; 3. Severe heart failure( above NYHA III level) or left ventricular ejection fraction (LVEF) 2.0 mg/dl or ongoing hemodialysis treatment, or known or medical records liver dysfunction, defined as cirrhosis or Child-Pugh >= B level; 5. Haemorrhage high risk or haemorrhagic tendency, disturbance of blood coagulation history, major gastrointestinal hemorrhage in 6 months, serious hematuria, some taboo for antiplatelet agents and anticoagulant therapy and so could not have antithrombotic therapy; 6. Cerebralvascular accident (CVA) or transient ischemic attack (TIA) in 6 months ago, or intracranial hemorrhage in past, or permanent neurological deficits, or any known intracranial lesion (aneurysma, arteriovenous malformations,etc.); 7. Known that have anaphylactic hypersensitivity for aspirin, clopidogrel, heparin, contrast agent, polylactide and rapamycin; 8. Have major surgical operation in 6 months; 9. Has haven organ transplantation or prepare to have it; 10. According to the followings to confirm instability arrhythmia, for example High Risk Idioventricular Incidence, Ventricular Tachycardia: (1) Need cumarin or any other oral chronic anticoagulation; (2) Possible haemodynamic instability due to arrhythmia; (3) Poor prognosis due to arrhythmia; 11. Need chemotherapy resulted from tumour; 12. Known immunosuppressive diseas or esautoimmune disease, plan to or be treating by immunosuppressive therapy ; 13. Plan to or be treating by choronic antigoagulation, heparin, warfarin, etc.; 14. Undergoing elective surgery in half year which needs to disuse aspirin,clopidogrel; 15. Routine blood examination indicates platelet count 700 x 10^9/L, white blood cell < 3 x 10^9/L; 16. Severe peripheral vasoneuropathy, could not use 6F catheter; 17. Has joined other clinical trails but not reached the primary end point; 18. Researcher judges the patient's poor medical compliance and could not complete the study as requested. QCA exlusion criterion: 1. Target lesion is in the left main coronary artery; 2. Severe triple vessels disease and all need revascularization;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Late lose of scaffold segment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate success rate (Target lesion success rate, Device success rate, Surgery success rate);Patient Oriented Composite Endpoint (all-cause death, all myocardial infarction and any revascularization);Thrombosis in scaffold;Angiographic endpoint [in-device, proximal and distal late lumen loss (LLL), In-device, in-segment, proximal and distal minimum lumen diameter (MLD)/diameter stenosis (DS)/angiographic binary restenosis (ABR)];Performances of delivery system;OCT Endpoint (1 year after the surgery: endometrial hyperplasis thickness, the least lumen area, proportion of covered struts, stent degradation rate in 1 year after the surgery and 3 years (only for the experimental group of OCT subgroup); | — |
Countries
China
Contacts
Public ContactYong Huo
Peking University First Hospital
Outcome results
None listed