STENTYS Self-expanding Versus Balloon-expandable Stent in Acute Myocardial Infarction (AMI)

Stent strut malapposition and stent underexpansion are a common phenomenon in AMI as a result of the changing anatomy after an AMI has occurred (thrombus dissolution, resolution of spasm) with the traditional balloon-expandable stent treatment. A self-expanding stent might lead to better stent strut apposition as it follows the contours of the vessel wall due to its self-expanding properties. This might result into better long term clinical outcomes like lower thrombosis rates.

Inclusion criteria

• Subject 18 years old.
• Acute Myocardial Infarction defined as presence of at least two of the three items below:

• Detection of rise of cardiac biomarkers with a least one value above the 99th percentile of the upper reference limit (URL)
• Symptoms of ischaemia (chest pain) >20 minutes
• ECG changes indicative of new ischaemia: new ST-T changes (ST deviation ≥0.2mV precordial leads and/or ≥0.1mV limb leads) or new LBBB)
• Reperfusion expected to be achieved within 12 hours from the onset of symptoms
• Subject understands the nature of the procedure and provides written informed consent prior to the catheterization procedure.
• Subject is willing to comply with specified follow-up evaluation and can be contacted by telephone.
• Acceptable candidate for coronary artery bypass graft (CABG) surgery.
• Male or non-pregnant female subject.

Angiographic Inclusion Criteria:

• Reference vessel diameter >2.5mm and <4.0mm by visual estimate.
• Target lesion <30mm in length by visual estimate

Exclusion criteria

• Currently enrolled in another investigational device or drug study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
• Coronary or cardiac intervention or major surgery of any kind within 30 days prior to the procedure.
• Target vessel supplied by by-pass vessel
• Patients on anticoagulation therapy (Coumadin)
• Patient received thrombolytic therapy.
• Myocardial infarction due to stent thrombosis, or infarct lesion at the side of a previously implanted stent
• Cardiogenic shock
• Any previous stent placement within 10mm (proximal or distal) of the target lesion.
• Co-morbid condition(s) that could limit the subject's ability to participate in the study or to comply with follow-up requirements, or impact the scientific integrity of the study.
• Concurrent medical condition with a life expectancy of less than 6 months.
• Left ventricular ejection fraction (LVEF) <30% at the most recent evaluation.
• Cerebrovascular accident or transient ischemic attack in the last 6 months.
• Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, or sensitivity to contrast media, which cannot be adequately pre-medicated.
• Known serum creatinine level >2.5mg/dl or presence or history of renal failure

Angiographic Exclusion Criteria:

• Unprotected left main coronary artery disease (obstruction greater than 50% in the left main coronary artery that is not protected by at least one non-obstructed bypass graft to the left anterior descending (LAD) or left circumflex (LCX) artery or a branch thereof).
• Target vessel is excessively tortuous (two bends >90˚ to reach the target lesion).
• Lesion location that is aorto-ostial or within 5mm of the origin of the LAD or LCX.
• Target lesion is severely calcified.