Status:
COMPLETED
Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stents to Treat De Novo Coronary Lesions
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Coronary Stenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 di...
Detailed Description
The primary endpoint is the incidence rate of TVR through 9 months post index procedure. In this protocol, TVR must be ischemia driven, based on the presence of symptoms, positive functional testing o...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Target lesion was located within or distal to a \> 60° bend in the vessel.
- Side branch of the target lesion included ostial narrowing ≥ 50% DS and was ≥ 2.0 mm diameter.
- Target lesion was totally occluded.
- Angiographic presence of probable or definite thrombus.
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
1108 Patients enrolled
Trial Details
Trial ID
NCT00301522
Start Date
February 1 2003
End Date
April 1 2009
Last Update
August 6 2010
Active Locations (72)
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1
Baptist Medical Center Princeton
Birmingham, Alabama, United States, 35211
2
Cardiovascular Associates PC/Baptist Medical Center Montclair
Birmingham, Alabama, United States, 35213
3
UAB Interventional Cardiology
Birmingham, Alabama, United States, 35294
4
Arizona Heart Institute and Hospital
Phoenix, Arizona, United States, 85006