Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System Clinical Study

Inclusion Criteria: subjects that participate in this study must fulfill all the following criteria: general inclusion criteria:

1. Age from 18 to 75 years old, man or non-pregnant woman;

2. Subjects with asymptomatic ischemic evidence, stable or unstable angina, or oldmyocardial infarction, suitable for selective PCI;

3. Subjects without contraindications of coronary artery bypass grafting (CABG);

4. Subjects are able to understand the purpose of this study, volunteer to participateand sign informed consent, willing to accept invasive imaging follow-up. Angiographic inclusion criteria:

5. One or two de novo target lesions

6. If subject has only one target lesion, the second non-target lesion can betreated but this non-target lesion must locate in a different epicardial vessel,and must be treated first and be treated successfully prior to the subjects'randomization.

7. If there are two target lesions, they must locate in different epicardial vesselsand both satisfy the angiographic eligibility criteria.

8. The definition of epicardial vessels means the left anterior descending artery (LAD), the left circumflex artery (LCX), and the right coronary artery (RCA) andtheir branches. Thus, for example, the subject must not have lesions requiringtreatment in both the LAD and a diagonal branch

9. Target lesion diameter stenosis ≥ 70% (or ≥ 50% simultaneously shall have clinicalevidence of myocardial ischemia), and TIMI flow grade ≥1; Target lesion length ≤24mm (visually); target lesion diameter between ≥ 2.5 mm to ≤ 4.00 mm.

10. Each target lesion can be fully covered by one stent.

Exclusion Criteria: If subjects fulfill any of below criterias, this subject shall be exclude from this study. general exclusion criteria:

1. Any newly onset acute myocardial infarction within 1 week or, myocardial enzymes doesnot return to normal level after myocardial infarction;

2. Target lesion has any stents implant history within 1 year or subjects planning toreceive percutaneous artery intervention within half one year;

3. Subjects with severe heart failure (≥ grade III NYHA) or left ventricular ejectionfraction <35% (accessed by ultrasound or left ventricular angiography)

4. Preprocedure severe kidney functional damaged: serum creatinine> 2.0mg /dl (176.8μmol / L) or subject is receiving hemodialysis;

5. Subjects with bleeding tendency, active gastrointestinal ulcers, history of cerebralhemorrhage or history of subarachnoid hemorrhage, history within six months ofischemic stroke, contraindications of anti-platelet agents and anticoagulantstreatment, and subjects cannot receive anti-thrombolytic therapy;

6. Hypersensitive or allergic to aspirin, clopidogrel, heparin, contrast agent,polylactic acid polymer， rapamycin;

7. The subject's life expectancy is less than 24 months;

8. Subjects participated in other drug or medical device clinical trial and have notreach the primary endpoint;

9. Investigators determine the subjects' compliance is poor, cannot complete the study asrequired;

10. Subjects have accepted substantial organ transplant or ready to undergo organtransplant;

11. Subjects have unstable arrhythmia, such as high-risk ventricular premature beats, andventricular tachycardia;

12. Subjects need to receive chemotherapy because of tumor;

13. Subjects have received or planning to receive coronary or chest radiotherapy;

14. Subjects with Immunosuppressive, autoimmune diseases, are planned or undergoingimmunosuppressive therapy;

15. Subjects are planning to receive or are receiving long-term anticoagulation therapy,such as heparin, warfarin and so on;

16. Subjects are planning to accept selective surgery within 6 months, need to discontinueaspirin or clopidogrel;

17. Blood tests showed that the platelet count is less than 100 × 109 / L, or over than 700 × 109 / L, the white blood cells count is less than 3 × 109 / L;

18. Diagnosed or suspected liver disease (such as hepatic cirrhosis);

19. Subjects with diffuse peripheral vascular disease, cannot use 6F catheter. angiographic exclusion criteria these exclusion criteria apply to the target or non-target lesion(s), target or non-targetvessel(s)

20. Target or non-target lesion(s) located in left main;

21. Subjects with coronary artery triple vessel lesion in LAD, LCX or RCA, all need to betreated. these exclusion criteria apply to the target lesion(s) or target vessel(s)

22. Target lesion located in left main;

23. Target lesion located in the aorto-ostial of RCA (within 3 mm of the origin of theRCA);

24. Target lesion located within 3 mm of the origin of the LAD and LCX;

25. Lesion involving a bifurcation with a:

26. Side branch ≥ 2.5 mm in diameter, or

27. Side branch with diameter stenosis ≥ 50%, or

28. Side branch requiring protection guide wire, or

29. Side branch requiring pre-dilatation.

30. Anatomy proximal to or within the lesion that may affect delivery of the Bioheart orXIENCE stent, including:

31. Extreme angulation (≥ 90°) proximal to or within the target lesion, or

32. Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion,or

33. Moderate or heavy calcification proximal to or within the target lesion

34. Target lesion involves a myocardial bridge.

35. Target vessel contains thrombus as indicated in the angiographic images or IVUS.

36. Prior to the index procedure target vessel has been previously treated with a stent atany time such that the Bioheart or XIENCE stent would need to cross the stent to reachthe target lesion.

37. Target vessel has been previously treated with a stent and the target lesion is within 5 mm proximal to a previously treated lesion.

38. Target lesion cannot reach the following outcomes, after the complete balloonpre-dilatation:

39. Residual (DS %) is < 40% (per visual estimation), ≤ 20% is strongly recommended;

40. TIMI Grade-3 flow (per visual estimation);

41. No angiographic complications (e.g., no-reflow, distal embolization, side branchclosure)

42. No dissections NHLBI grade D-F;

43. No chest pain lasting > 5 minutes, and;

44. No ST depression or elevation lasting > 5 minutes.