A Safety Study of ABI-007 for In-Stent Restenosis

Inclusion Criteria: * Undergone a successful and uncomplicated de novo stent placement in up to two native coronary arteries * Diagnosis of angina pectoris * At least 18 yrs old * If female, negative pregnancy test, non-lactating, and agree to utilize methods to prevent pregnancy * No previous treatment for In-Stent Restenosis * Patient agrees to comply with follow-up evaluation * Informed Consent obtained * Target vessel at least 3 mm diameter * Total stent less than 25 mm * Left ventricular ejection fraction at least 30% * No more than a single stent will be used per lesion * No more than one stented lesion per vessel with the exception that 2 lesions in a single vessel are allowable if covered by less than 25 mm of continuous stent * By Intravascular Ultrasound (IVUS), stent is fully opposed and has a minimum diameter of 3 mm or an in-stent luminal area of at least 7 mm2 * TIMI 3 coronary flow post-stenting * No angiographic evidence of thrombus post-stenting General Exclusion Criteria: * More than two lesions treated with Percutaneous Coronary Intervention (PCI) or it is anticipated that additional lesions will require treatment within two months * Previous PCI within preceding three months * Previous participation in another study within 30 days * Life expectancy less than 12 months * Factors making follow-up difficult * Intended surgical intervention within 6 months of study participation * Investigator decision that patient is unsuitable * Recipient of heart transplant * Q wave or non-Q wave Myocardial Infarction (MI) with documented total CK greater than 2X normal upper limits within the preceding 24 hrs and the CK and CK-MB enzymes remain above normal at the time of the procedure * Cardiogenic shock * May refuse blood transfusion * Gastro-intestinal bleeding within past 3 months * Platelet count less than 100,000 cells/mm3 * Impaired renal function * Known allergies/hypersensitivity to aspirin, clopidogrel bisulfate, and/or stainless steel Exclusion Criteria Related to Angioplasty: * Intervention for another lesion occurred within 90 days or is planned for within 60 days after the index procedure * Stent is located in a coronary bypass * Unprotected left main disease with greater than 50% stenosis * Lost a side branch greater than 2 mm during stenting procedure * Angiographic evidence of thrombus post-stenting * Prior stent within 5 mm of target lesion * Left ventricular ejection fraction less than 30% * Greater than 50% stenosis proximal or distal to target lesion * Malposition, dissection, or unmasking of a significant narrowing in the inflow or outflow area of the implanted stent * Patient has received a drug coated stent as part of this procedure Exclusion Criteria Related to ABI-007: * Absolute neutrophil count is less than 1500 cells/mm3 * Platelet count is less than 100,000 cells/mm3 * Bilirubin greater than 1.5 mg/dl or SGOT and SGPT greater than 2.5X upper limit of normal or alkaline phosphatase greater than 2.5X upper limit of normal * Creatinine greater than 2.5X upper limit normal * Pre-existing peripheral neuropathy of NCI toxicity Criteria Scale of Grade greater than 1 * Immunosuppressed or has HIV or AIDS * Hypersensitivity to Taxane