• Incidence of any procedural complications [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
• to determine a safe and appropriate intracoronary dose for future clinical trials of ABI-007 administered to patients after successful PTCA and stenting of de novo lesions or angioplasty of ISR lesions [ Time Frame: 6 months ] [ Designated as safety issue: No ]
• to evaluate the incidence of treatment-emergent adverse events and serious adverse events [ Time Frame: 6 months ] [ Designated as safety issue: No ]

• The primary objective of the study is to determine the feasibility of intracoronary administration, and to determine a safe and appropriate intracoronary dose for
• future clinical trials of ABI-007 administered to patients after successful PTCA and stenting of de novo lesions or angioplasty of ISR lesions, and to evaluate the
• incidence of treatment-emergent adverse events and serious adverse events.

The purpose of this study is to investigate the use of systemic intracoronary administration of albumin-bound paclitaxel, ABI-007, for the prevention and reduction of restenosis following de novo stenting or following angioplasty for 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.
• 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 ≥2.5mm diameter (by angiography).
• Each de novo lesion is such that it is stented with ≤ 25mm of single continuous stent.
• Each in-stent restenosis (ISR) lesion is ≤ 25mm in length.
• There is at least 5mm 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 2.5mm or an in-stent luminal area ≥5.0mm2
• 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 PCI, or it is anticipated that additional lesions will require treatment within 2 months.
• Previous percutaneous coronary intervention (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 CK≥2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remain above normal at the time of the procedure.
• Cardiogenic shock: sustained systolic blood pressure (SBP) less than 80mmHg, with no response to fluids or SBP less than 100mmHg 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 < 150,000 cells/mm3;
  • Absolute neutrophil count (ANC) < 2000 cells/mm3;
  • Hemoglobin (HGB) <9g/dl;
  • Total bilirubin >1.5mg/dl;
  • ALT (SGPT) > 2.5 x upper limit of normal range (ULN);
  • AST (SGOT) > 2.5 x upper limit of normal range (ULN);
  • Alkaline phosphatase > 2.5 x upper limit of normal (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.