Please select the eligibility criteria that correspond to the clinical trial below.
Title: Trial to Assess the Use of the Cypher TM Stent in Acute Myocardial Infarction Treated With Balloon Angioplasty
Brief Summary: The main objective of this study is to assess the effectiveness and safety of the CYPHER™ (CYPHER SELECT™) (Sirolimus-eluting) stent in reducing the occurrence of a composite endpoint of target vessel failure (TVF) in subjects treated for acute myocardial infarction as compared to a bare metal stent.


Options:
A: Inclusion Criteria:

1. Be aged \>=18 years at the time of randomization.
2. Have symptoms which include at least 10 minutes of angina or anginal equivalent that the investigator believes has a high likelihood of being ischemic in origin within the 24 hours prior to randomization consistent with a diagnosis of Unstable Angina/Non-ST Elevation Myocardial Infarction (UA/NSTEMI) (patients with symptoms atypical for cardiac ischemia should not be enrolled).
3. Meet at least one of the following criteria for UA/NSTEMI:

   1. All of the following four features: \*Age \>= to 65 years; \*aspirin taken within the last 7 days; \*two or more episodes of angina in the last 24 hours; \*three or more of the following risk factors: hypertension, high cholesterol, family history, diabetes, current smoker OR
   2. ECG changes: New or presumably new ST-segment depression \>=0.1 MV (\>=1mm), or transient (\<30 minutes) ST-segment elevation \>=0.1MV (\>=1mm) in at least 2 contiguous leads, OR
   3. Abnormal cardiac enzymes within the 24 hours before enrollment defined as elevated troponin I, T or creatine phosphokinase-MB isoenzyme (CPK-MB) level greater than the site's upper limit of normal (ULN) OR
   4. History of coronary artery disease with documentation of one of the following: \*prior angiography (coronary stenosis of \>50%); \*prior PCI or Coronary Artery Bypass Grafting (CABG); \*prior definite, documented myocardial infarction.
4. Provide written informed consent before initiation of any study related procedures.

Exclusion Criteria:

1. Anticipated inability to perform angiography within 72 hours of randomization and anticipated inability to perform any intervention required (PCI or CABG) within the index hospitalization.
2. ST segment elevation of \>1 mm in 2 contiguous ECG leads lasting for \>30 minutes, or new left bundle branch block, or a clinical syndrome consistent with acute evolving transmural MI requiring immediate thrombolytic or interventional reperfusion therapy.
3. Cardiogenic shock (systolic blood pressure \<80 mmHg for \>30 minutes not responding to intravenous fluids, or requiring intravenous pressor agents or an intra-aortic balloon pump).
4. Bleeding diathesis or any history of hemorrhagic stroke or other intra-cerebral bleed, cerebral arteriovenous malformation, cerebral aneurysm or prior ischemic stroke within the last 2 years, or any prior stroke with residual neurologic deficit. Gastrointestinal or genitourinary bleeding within the last 2-weeks.
5. Platelet count \<100,000 cells/mm3 at baseline, or history of heparin induced thrombocytopenia
6. Patients on warfarin or phenprocoumon, unless they can be safely discontinued and the baseline INR is \< 1.5 times control.
7. Allergy to pork or pork products.
8. Patients who have been started on and received 2 or more doses of low molecular weight heparin for the current admission prior to randomization (patients who have received one dose of low molecular weight heparin may still be enrolled.
9. Patients who have been started on bivalirudin in the 6 hours prior to randomization
10. Thrombolytic therapy or abciximab use within the last 24 hours.
11. Treatment with a GPIIb/IIIa inhibitor at the time of randomization, which cannot be discontinued.
12. Patients on Arixtra (fondaparinux).
13. Absolute contraindication or allergy to:

    * any one of enoxaparin, unfractionated heparin, bivalirudin or aspirin
    * both abciximab and eptifibatide
    * both eptifibatide and tirofiban
    * iodinated contrast which cannot be pre-medicated
14. Contraindications to angiography, including but not limited to severe peripheral vascular disease.
15. Angina from secondary causes.
16. Pregnancy or nursing mothers. Women of child bearing potential must have a negative urine or serum pregnancy test prior to enrollment.
17. Calculated serum creatinine clearance \< 30 mL/min (Determined by the Cockcroft Gault formula: ((140-age in yrs) x weight in kg)/(814.464 x Creatinine in mmol/l) or /(72 x \[Creatinine in mg/dL\]). For women, multiply by 0.85.
18. Previous enrollment in this study.
19. Patients currently enrolled in another investigational drug study that has not completed the follow-up phase.
B: Inclusion Criteria:

1. Have prolonged, continuous (lasting at least 20 minutes) chest pain despite administration of nitrates and onset within 12 hours of randomization, and one of the following:

   1. ST segment elevation \>=1mm in standard leads and \>=2mm in 2 or more contiguous precordial leads with reciprocal ST depression
   2. New or presumably new left bundle branch block (LBBB)
2. The culprit lesion must be identified on a de novo native coronary artery and an emergency angioplasty must be possible. The culprit site must be visualized before the stent implantation;

Exclusion Criteria:

1. Killip class \> 2 upon arrival to the cath-lab;
2. Significant (\>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede inflow or runoff;
3. Evidence of massive thrombus in the infarct related artery distally to the culprit lesion;
4. Documented left ventricular ejection fraction \<=30%;
5. Target lesion is located in an arterial or venous by-pass graft;
6. ECG documented evidence of prior myocardial infarction;
7. Patient who received thrombolytic therapy for the current AMI before enrollment in this study.
C: Inclusion Criteria:

* Clinical symptoms of STEMI, with initial onset of chest pain within the past 12 hours, an ECG demonstrating \> 0.1 mV ST-segment elevation in 2 or more contiguous leads or documented new left bundle-branch block and were suitable candidates for percutaneous revascularization.

Exclusion Criteria:

* Active internal bleeding or a history of bleeding diathesis within the previous 30 days
* An history of intracranial hemorrhage
* Intracranial neoplasm
* Arteriovenous malformation or aneurysm
* Known allergy to sirolimus
* Paclitaxel
* Heparin, aspirin, or clopidogrel
* An history of stroke within 30 days or any history of hemorrhagic stroke
* History, symptoms, or findings suggestive of aortic dissection, fibrinolytic therapy within 24 hours
* History of thrombocytopenia, pregnancy, patients on warfarin or acenocoumarol within the last seven days
* Inability to obtain the informed consent
D: Inclusion Criteria:

* Must have clinical symptoms consistent with AMI (e.g., angina or anginal equivalent)lasting \>20 minutes but \<12 hours in duration;
* ST-segment elevation of \>1 mm in \>2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of \>1 mm in \>2 contiguous anterior leads;
* The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent.

Exclusion Criteria:

* The patient has a known hypersensitivity or contraindication to any of the following medications:

  * Heparin, pork or pork products
  * Both abciximab and eptifibatide
  * Aspirin
  * Both Clopidogrel and Ticlopidine
  * Bivalirudin
  * Paclitaxel or Taxol
  * The polymer components of the TAXUS™ stent (SIBS)
  * Stainless steel and/or
  * Contrast media;
* Prior administration of thrombolytic therapy, bivalirudin, GP IIb/IIIa inhibitors, low molecular weight heparin or fondaparinux for this admission. Patients receiving prior unfractionated heparin may be enrolled, and treated per randomization;
* Current use of coumadin;
* Systemic (intravenous) Paclitaxel or Taxol use within 12 months;
* Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plans to become pregnant any time after enrollment into this study;
* History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions;
* History of intra-cerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke;
* Stroke or transient ischemic attack within the past 6 months, or any permanent residual neurologic defect;
* Gastrointestinal or genitourinary bleeding within the last 2 months, or major surgery within six weeks;
* Recent history or known current platelet count \<100,000 cells/mm3 or Hgb \<10 g/dL;
* Extensive peripheral vascular disease, such that emergent angiography and intervention in the opinion of the investigator is likely to be difficult or complicated;
* An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first six months post enrollment;
* Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance;
* Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period;
* Previous enrollment in this trial;
* Patients who underwent coronary stent implantation within the past 30 days.

Answer: B