Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stents to Treat De Novo Coronary Lesions

Completed · Phase 2/Phase 3

Conditions studied: Coronary Stenosis

In brief

The primary objective of this study is to further evaluate the safety and effectiveness of the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System in long lesion lengths, small and large vessel diameters and with multiple overlapping stents in the treatment of de novo coronary artery lesions

Key facts

Study ID

NCT00301522

Run by

Boston Scientific Corporation

People needed

1108

Starts

2003-02-01

Expected to finish

2009-04-01

Last updated by the study team

2010-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient was ≥ 18 years old.
• Eligible for percutaneous coronary intervention.
• Documented stable angina pectoris.
• LVEF of greater than 25%.
• Acceptable candidate for coronary artery bypass grafting.
• Target lesion segment is located within a single native coronary vessel.
• Target lesion was de novo.
• RVD was greater than 2.25 mm and less than 4.0 mm .and patient and/or lesion fulfilled protocol defined subgroups.
• Cumulative target lesion length was greater than 10 mm and less than 46mm assessed after pre-dilatation with standard balloon or cutting balloon angioplasty, including adjacent areas of dissection that were covered.
• Target lesion diameter stenosis less than 50% before pre-dilatation .
• Vessel and lesion morphology such that the lesion was treated only with study stent(s); no planned use of commercial stents.

You may not qualify if…

• Known hypersensitivity to paclitaxel.
• Any previous or planned treatment with a non-study anti-restenotic drug-coated or drug-eluting coronary stent.
• Planned use of both the study stent and a non-study stent in the treatment of the target vessel.
• Previous or planned treatment with intravascular brachytherapy in the target vessel.
• Recent MI.
• CK-MB greater than 2x the local laboratory's upper limit of normal.
• Cerebrovascular accident within 6 months of randomization.
• Planned CABG ≤ 9 months post index procedure.
• Acute or chronic renal dysfunction.
• Leukopenia.
• Thrombocytopenia or thrombocytosis.
• Active peptic ulcer or active gastrointestinal bleeding, or previously active within 6 months.
• Known allergy to stainless steel.
• Any prior true anaphylactic reaction to contrast agents.
• Contraindication to ASA or to both clopidogrel and ticlopidine.
• Patient was on warfarin or it was anticipated that treatment with warfarin would have been required during any period within 6 months post the index procedure.
• Patient was or had been treated with chemotherapeutic agents within 12 months of the index procedure.
• Anticipated treatment with paclitaxel, oral rapamycin or colchicine during any period in the 9 months post index procedure.
• Male or female with known intention to procreate within 3 months post index procedure.
• Co-morbid condition(s) that could limit the patient's ability to participate in the study, limit compliance with follow-up requirements or impact the scientific integrity of the study.
• Planned surgical procedure requiring withdrawal of any anti-platelet therapy within 6 months post index procedure.
• Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
• Unprotected left main coronary artery disease.
• Target lesion was ostial in location.
• Target lesion and/or target vessel proximal to the target lesion was moderately or severely calcified.

Where it is running

• Cardiovascular Associates PC/Baptist Medical Center Montclair — Birmingham, Alabama, United States
• UAB Interventional Cardiology — Birmingham, Alabama, United States
• Arizona Heart Institute and Hospital — Phoenix, Arizona, United States
• Scripps Memorial Hospital LaJolla — La Jolla, California, United States
• University of California Davis Medical Center — Sacramento, California, United States
• Mercy General Hospital — Sacramento, California, United States
• Stanford Medical Center — Stanford, California, United States
• Aurora Denver Cardiology — Aurora, Colorado, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Palm Beach Heart Research Institute, LLC — Atlantis, Florida, United States
• Clearwater Cardiovascular and Interventional Consultants — Clearwater, Florida, United States
• Miami International Cardiology Consultants — Miami Beach, Florida, United States
• Mediquest Research Group, Inc. — Ocala, Florida, United States
• Florida Hospital — Orlando, Florida, United States
• The Heart & Vascular Institute of Florida — Safety Harbor, Florida, United States
• Piedmont Hospital — Atlanta, Georgia, United States
• Emory University Hospital — Atlanta, Georgia, United States
• St. Joseph's Hospital of Atlanta — Atlanta, Georgia, United States
• Evanston Northwestern Health Care — Evanston, Illinois, United States
• Midwest Heart Foundation — Lombard, Illinois, United States
• Shawnee Mission Medical Center — Shawnee Mission, Kansas, United States
• Central Baptist Hospital — Lexington, Kentucky, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Maine Medical Center — Portland, Maine, United States
• Baptist Medical Center Princeton — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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