Status:
COMPLETED
A Safety Study of ABI-007 for In-Stent Restenosis
Lead Sponsor:
Celgene
Conditions:
Angina Pectoris
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This trial will treat patients with a new chemotherapeutic medicine who have undergone a successful and uncomplicated de novo stent placement in up to two native coronary arteries. The purpose of the ...
Detailed Description
See inclusion/exclusion criteria.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00093223
Start Date
September 1 2001
End Date
December 1 2007
Last Update
November 18 2019
Active Locations (1)
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1
Abraxis BioScience, Inc.
Durham, North Carolina, United States, 27703