A First-in-Man Study of the Firesorb BVS (FUTURE-I)

Exclusion Criteria

• •1. Within 1 week of any acute myocardial infarction or myocardial enzymes did not return to normal;
• •2. Implantation of stent in target vessel within 1 year , patients with planned intervention again within six months;
• •3. Severe congestive heart failure (NYHA class III and above) ,left ventricular ejection fraction or \<40% (ultrasound or left ventricular angiography);
• •4. Preoperative renal function serum creatinine \>2.0mg/DL; receiving hemodialysis;
• •5. Bleeding, active gastrointestinal ulcers, brain hemorrhage or subarachnoid hemorrhage and half year history of ischemic stroke, antiplatelet agents and would not allow an anticoagulant therapy contraindications patients undergoing antithrombotic therapy;
• •6. Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer and rapamycin allergies;
• •7. The patient's life expectancy is less than 12 months;
• •8. Top participated in other drug or medical device and does not meet the primary study endpoint in clinical trials time frame;
• •9. Researchers determine patient compliance is poor, unable to complete the study in accordance with the requirements;
• •10. Heart transplantation patients;
• •11. The unstable arrhythmia, such as high risk ventricular extrasystole and ventricular tachycardia;
• •12. Cancer need chemotherapy;
• •13. Immunosuppression and autoimmune diseases, planned or undergoing immunosuppressive therapy;
• •14. Planning or being receiving long-term anticoagulant therapy, such as heparin, warfarin, etc;
• •15. Within six months for elective surgery requires stopping aspirin, Clopidogrel patients;
• •16. Blood test prompted platelet counts of less than 100x10E9/L or greater than 700x10E9/L, white blood cells than 3x10E9/L; known or suspected liver disease (such as hepatitis);
• •17. Peripheral vascular disease, 6F catheter is not available.