Stentys Coronary Stent System Clinical Trial in Patients With Acute Myocardial Infarction

Inclusion Criteria: General Inclusion Criteria

1. Subject ≥ 18 years old.

2. Subject experiencing clinical symptoms consistent with AMI of >30 min. in duration.

3. ST elevation ≥1 mm in ≥2 contiguous leads or new left bundle branch block, or trueposterior MI with ST depression of ≥1 mm in ≥2 contiguous anterior leads.

4. Symptom duration is <12 hours prior to signing informed consent.

5. Subject should be in catheterization laboratory and procedure started within 2 hoursof consent.

6. Patient provides written informed consent.

7. Patient agrees to all required follow-up procedures and visits. Angiographic Inclusion Criteria

8. Based on coronary anatomy, PCI is indicated for the culprit lesion with anticipateduse of stenting.

9. The vessel diameter is either known or expected to be 2.5-4.0mm, without excessivetortuosity or diffuse distal disease.

10. Lesion length ≥12mm and ≤ 23mm

Exclusion Criteria: General Exclusion Criteria

1. Currently enrolled in another investigational device or drug trial that has notcompleted the primary endpoint or that clinically interferes with the current studyendpoints.

2. A previous coronary interventional procedure of any kind within 30 days prior to theprocedure.

3. Female patients of childbearing potential known to be pregnant.

4. Patients undergoing cardiopulmonary resuscitation.

5. Cardiogenic shock (SBP <80 mmHg for >30 minutes, or requiring IV pressors or emergencyIABP for hypotension).

6. The subject requires multivessel PCI at time of index procedure or any stagedprocedure of the target vessel within 9 months or any non-target vessel within 30 dayspost-procedure.

7. The target lesion requires treatment with a device other than PTCA prior to stentplacement (such as, but not limited to, directional coronary atherectomy, excimerlaser, rotational atherectomy, etc.). Thrombus aspiration may be used per operatordiscretion.

8. Attempted thrombolysis.

9. Co-morbid condition(s) that could limit the subject's ability to participate in thetrial or to comply with follow-up requirements, or impact the scientific integrity ofthe trial.

10. Concurrent medical condition with a life expectancy of less than 12 months.

11. Known left ventricular ejection fraction (LVEF) < 25% at the most recent evaluation (prior to the index hospitalization).

12. History of cerebrovascular accident or transient ischemic attack in the last 6 months.

13. Active peptic ulcer or active gastrointestinal (GI) bleeding.

14. History of bleeding diathesis or coagulopathy or inability to accept bloodtransfusions.

15. Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin,clopidogrel or ticlopidine, cobalt, nickel, or sensitivity to contrast media, whichcannot be adequately pre-medicated.

16. Known serum creatinine level > 2.5 mg/dl, eGFR <30, or hemodialysis dependent. Angiographic Exclusion Criteria

17. Unprotected left main coronary artery disease (obstruction greater than 60% in theleft main coronary artery that is not protected by at least one non-obstructed bypassgraft to the left anterior descending (LAD) or left circumflex (LCX) artery or abranch thereof).

18. Multi-vessel intervention required during the index procedure.