Comparison of the Conor Sirolimus-eluting Coronary Stent to the Taxus Liberte Paclitaxel-eluting Coronary Stent in the Treatment of Coronary Artery Lesions (NEVO RES-I)

This is an interventional treatment trial for Coronary Atherosclerosis focused on measuring Coronary artery disease, drug-eluting stents, sirolimus-eluting coronary stents Read More

Inclusion Criteria:

• 18 years of age or older
• Eligible for percutaneous coronary intervention and coronary artery bypass graft surgery.
• Diagnosis of stable or unstable angina or silent ischemia
• Left ventricular ejection fraction >30%
• The subject requires treatment of a single de novo lesion in a native coronary artery.
• Lesion to be treated is less than or equal to 28 mm in length in a vessel that is 2.5-3.5mm diameter.
• The target lesion diameter stenosis is >50% and <100% by visual estimate.
• The target lesion is a minimum of 10 mm distance from any previously treated segment of the target vessel.
• The subject understands the study requirements, is willing to comply with all study procedures and has provided written informed consent.

Exclusion Criteria:

• The subject has undergone coronary revascularization to any vessel within 30 days.
• The subject has undergone target vessel revascularization within 6 months.
• Treatment of more than one qualifying lesion is required at the time of enrollment, or is planned within 30 days following enrollment.
• The subject has known sensitivity to sirolimus, paclitaxel, the polymeric matrices, stainless steel or cobalt chromium.
• There is planned treatment of the target lesion with any device other than the pre-dilatation balloon angioplasty catheter.
• The subject had a myocardial infarction within 72 hours, or presents with CK elevation > 2 times upper limit normal associated with elevated CK-MB.
• The subject is in cardiogenic shock.
• The subject had a cerebrovascular accident within the past 6 months.
• The subject has acute or chronic renal dysfunction (defined as creatinine >2.0 mg/dl).
• The subject has a contraindication to aspirin or clopidogrel.
• The subject has thrombocytopenia (platelet count < 100,000/mm3.
• The subject has had active gastrointestinal bleeding within the past 3 months.
• The subject has a known bleeding or hypercoagulable disorder.
• The subject has had prior anaphylactoid reaction to contrast agents or has contrast sensitivity that cannot be controlled with pre-medication.
• The subject is currently taking immunosuppressant therapy.
• The subject is currently, or has been treated wtih either Rapamune or paclitaxel within 12 months of the procedure.
• The subject is a female with a positive pregnancy test or is lactating.
• The subject has an active infection.
• The subject has co-morbidities that could interfere wtih completion of study procedures, or life expectancy less than 24 months.
• The subject is participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study.

Angiographic Exclusion Criteria

• Left main disease >50% diameter stenosis.
• The target lesion is ostial.
• The target lesion or target vessel are severely calcified.
• The target lesion involves a bifurcation with diseased branch vessel greater than or equal to 2.0 mm that would require intervention or protection.
• The target lesion has TIMI o or TIMI I flow.
• Angiographic evidence of thrombus.
• The target vessel has had prior stent placement.
• The patient has had prior coronary brachytherapy.
• There is angiographic restenosis of any previously treated segment of the target vessel, or atherosclerotic area wtih >50% diameter stenosis outside of the target lesion.
• The subject has undergone prior CABG.