Status:
COMPLETED
Use of Nanoparticle Paclitaxel (ABI-007) for the Prevention of In-Stent Restenosis
Lead Sponsor:
Celgene Corporation
Conditions:
Coronary Restenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study was to investigate the use of systemic intracoronary administration of albumin-bound paclitaxel, ABI-007, for the prevention and reduction of restenosis following de novo ste...
Detailed Description
This study consisted of a Phase I non-randomized dose escalation phase to determine the maximum tolerated dose and a randomized Phase II component to assess preliminary efficacy. Nanoparticle paclitax...
Eligibility Criteria
Inclusion
- 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
- 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 \< 150,000 cells/mm\^3;
- Absolute neutrophil count (ANC) \< 2000 cells/mm\^3;
- Hemoglobin (HGB) \<9 g/dl;
- Total bilirubin \>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.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00124943
Start Date
July 1 2005
End Date
August 1 2009
Last Update
April 2 2012
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