Use of Nanoparticle Paclitaxel (ABI-007) for the Prevention of In-Stent Restenosis

Inclusion Criteria

• Male or non-pregnant and non-lactating female, and ≥ 18 years of age.
• Diagnosis of angina pectoris or unstable angina pectoris or patients with documented silent ischemia.
• Left ventricular ejection fraction ≥30%
• Patient has undergone successful and uncomplicated stenting of up to 2 de novo lesions in native coronary arteries OR patient has undergone successful and uncomplicated balloon angioplasty of up to 2 in-stent restenosis (ISR) lesions in native coronary arteries, but not both.
• Thrombolysis In Myocardial Infarction (TIMI) 3 coronary flow post-stenting for de novo lesions or post balloon angioplasty for ISR lesions.
• No angiographic evidence of thrombus post-procedure.
• Target vessel ≥2.5 mm diameter (by angiography).
• Each de novo lesion is such that it is stented with ≤ 25 mm of single continuous stent.
• Each in-stent restenosis (ISR) lesion is ≤ 25 mm in length.
• There is at least 5 mm of non-diseased vessel on either side of target lesion(s).
• By intravascular ultrasound (IVUS), stent is fully opposed and has a minimum diameter of 2.5 mm or an in-stent luminal area ≥ 5.0 mm^2
• Patient or guardian has provided a signed written informed consent to participate in the study and in all follow-up assessments using a form that is approved by the local Institutional Review Board (IRB)/Ethics Committee of the investigative site.

Exclusion Criteria

• Target de novo lesion was treated with a drug-eluting stent
• Target ISR lesion requires any treatment other than balloon angioplasty
• Patient has both a de novo lesion and an ISR lesion.
• If more than 2 lesions are treated with percutaneous coronary intervention (PCI), or it is anticipated that additional lesions will require treatment within 2 months.
• Previous PCI within preceding two months.
• Intended surgical intervention within 6 months of enrollment in the study.
• Unprotected left main disease with >50% stenosis
• Malapposition, dissection, or unmasking of a significant narrowing in the inflow or outflow area of the implanted stent.
• Women who are pregnant and women of child bearing potential who do not use adequate contraception
• Previous participation in another study with any investigational drug or device within the past 30 days or current enrollment in any other clinical protocol or investigational drug or device trial.
• Patient has a life expectancy of less than 12 months or there are factors making clinical and/or angiographic follow-up difficult
• Any significant medical condition which, in the investigator's opinion, may interfere with the patient's optimal participation in the study
• Heart transplant candidate or recipient
• Patient is immunosuppressed or is HIV positive.
• Patient has experienced a Q wave or a non Q wave myocardial infarction (MI) with documented total creatine kinase (CK) ≥2 times normal within the preceding 24 hours and the CK and creatine kinase-MB fraction (CK-MB) enzymes remain above normal at the time of the procedure.
• Cardiogenic shock: sustained systolic blood pressure (SBP) less than 80 mmHg, with no response to fluids or SBP less than 100 mmHg with vasopressors (in absence of bradycardia)
• Any individual who may refuse a blood transfusion
• Documented major gastro-intestinal bleeding within 3 months
• The following lab values at baseline are exclusionary:
• Serum creatinine > 2.5 mg/dl;
• Platelet count 1.5 mg/dl;
• Alanine Aminotransferase (SGPT) > 2.5 x upper limit of normal range (ULN);
• Aspartate Aminotransferase (SGOT) > 2.5 x ULN;
• Alkaline phosphatase > 2.5 x ULN.
• Known allergy/hypersensitivity/contraindication to the study drug; to any taxanes; or to any required study treatment: aspirin, clopidogrel bisulfate, stent materials
• Pre-existing peripheral neuropathy of National Cancer Institute (NCI) Toxicity Grade > 1.