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.
