A Trial of Firesorb in Patients With Coronary Artery Disease: FUTURE-II

General Inclusion Criteria:

1. 18-75 years of age, males or non-pregnant females;

2. With silent ischemia evidence, patients with stable or unstable angina, or inpatients with old myocardial infarction;

3. Patients with indications for coronary artery bypass graft surgery;

4. To understand the purpose of testing, voluntary and informed consent, patientsundergoing invasive imaging follow-up.

Angiographic Inclusion Criteria:

1. One or two de novo target lesions:

2. If there is one target lesion, a second non-target lesion may be treated butthe non-target lesion must be present in a different epicardial vessel, andmust be treated first with a successful, uncomplicated result prior torandomization of the target lesion.

3. If two target lesions are present, they must be present in different epicardialvessels and both must satisfy the angiographic eligibility criteria.

4. The definition of epicardial vessels means the LAD, LCX and RCA and theirbranches. Thus, the patient must not have lesions requiring treatment in e.g.both the LAD and a diagonal branch.

5. Target lesion(s) must be located in a native coronary artery with a visuallyestimated or quantitatively assessed % diameter stenosis (DS) of ≥ 50% and < 100%with a thrombolysis in myocardial infarction (TIMI) flow of ≥1 and one of thefollowing: stenosis ≥ 70%, an abnormal functional test (e.g. fractional flowreserve, stress test), unstable angina or post-infarct angina. Lesion(s) must belocated in a native coronary artery with RVD by visual estimation of ≥ 2.5 mm and ≤4.0 mm. Lesion(s) must be located in a native coronary artery with length by visualestimation of ≤ 25 mm.

6. Each target lesion may be covered with one stent.

General Exclusion Criteria:

1. Within 1 week of any acute myocardial infarction or myocardial enzymes did notreturn to normal;

2. Implantation of stent in target vessel within 1 year , patients with plannedintervention again within six months;

3. Severe congestive heart failure (NYHA III and above) ,or left ventricular ejectionfraction <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 subarachnoidhemorrhage and half year history of ischemic stroke, antiplatelet agents and wouldnot allow an anticoagulant therapy contraindications patients undergoingantithrombotic therapy;

6. Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer andrapamycin 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 studyendpoint in clinical trials time frame;

9. Researchers determine patient compliance is poor, unable to complete the study inaccordance with the requirements;

10. Heart transplantation patients;

11. The unstable arrhythmia, such as high risk ventricular extrasystole and ventriculartachycardia;

12. Cancer need chemotherapy;

13. Immunosuppression and autoimmune diseases, planned or undergoing immunosuppressivetherapy;

14. Planning or being receiving long-term anticoagulant therapy, such as heparin,warfarin, etc;

15. Within six months for elective surgery requires stopping aspirin, Clopidogrelpatients;

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 (suchas hepatitis);

17. Peripheral vascular disease, 6F catheter is not available.

Angiographic Exclusion Criteria:

1. left main coronary artery disease;

2. severe triple vessel lesion and required revascularization.

The following exclusion criteria apply to the target lesion(s) or target vessel(s):

1. Aorto-ostial right coronary artery (RCA) lesion (within 3 mm of the ostium).

2. Lesion located within 3 mm of the origin of the Left Anterior Descending Artery (LAD) or left circumflex artery (LCX).

3. Lesion involving a bifurcation with a:

4. side branch ≥ 2.5 mm in diameter, or

5. side branch with diameter stenosis ≥ 50%, or

6. side branch requiring guide wire, or

7. side branch requiring dilatation.

8. Anatomy proximal to or within the lesion that may impair delivery of Firesorb orXIENCE stent:

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

10. Excessive tortuosity (≥ two 45° angles) proximal to or within the targetlesion.

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

12. Lesion or vessel involves a myocardial bridge.

13. Vessel contains thrombus as indicated in the angiographic images or by IVUS or OCT.

14. Vessel has been previously treated with a stent at any time prior to the indexprocedure such that the Firesorb or XIENCE would need to cross the stent to reachthe target lesion.

15. Vessel has been previously treated and the target lesion is within 5 mm proximal ordistal to a previously treated lesion.

16. Lesion which prevents successful balloon pre-dilatation, defined as full balloonexpansion with the following outcomes:

17. Residual %DS is a maximum of < 40% (per visual estimation), ≤ 20% is stronglyrecommended.

18. TIMI Grade-3 flow (per visual estimation).

19. No angiographic complications (e.g. distal embolization, side branch closure).

20. No dissections National Heart Lung and Blood Institute (NHLBI) grade D-F.

21. No chest pain lasting > 5 minutes.

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