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