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

See inclusion/exclusion criteria.

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