Status:
COMPLETED
Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stent in the Treatment of In-Stent Restenosis
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Coronary Restenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The objective of this study is to evaluate the safety and effectiveness of the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System as compared to brachytherapy in patients experiencing in-stent re...
Detailed Description
Percutaneous approaches to in-stent restenosis (ISR) have included balloon angioplasty alone, rotational atherectomy, cutting balloon angioplasty, directional coronary atherectomy, excimer laser angio...
Eligibility Criteria
Inclusion
- Cumulative target lesion length is \</= 46 mm (visual estimate).
- Reference vessel diameter (RVD) is \>/= 2.5 and \</= 3.75 mm (visual estimate)
- Left ventricular ejection fraction (LVEF) is \>/= 25%
Exclusion
- Any previous or planned treatment with a non-study anti-restenotic drug-coated or drug-eluting coronary stent in the target vessel. (Note:previous or planned treatment with heparin or phosphorylcholine coated stents is acceptable, as long as, the procedure with the non-study stent meets the protocol defined criteria for non-target lesion interventions.)
- Previous or planned treatment with intra-coronary brachytherapy (gamma or beta source) in the target vessel
- Previous external radiotherapy to the heart or target vessel area
- Known genetic radiation sensitivity disorders (i.e. ataxia-telangiectasia, etc.)
- Side branch of the target lesion includes ostial narrowing \>/= 50% diameter stenosis (DS) and is \>/= 2.0 mm diameter
- Target lesion has been previously treated for ISR with the placement of a second stent(s), which covers \>/= 50% of the original stent length (a true "stent sandwich")
- Target vessel is pre-treated with an unapproved device, directional or rotational coronary atherectomy, laser, or transluminal extraction catheter immediately prior to delivery of randomized treatment (stent placement or intra-coronary brachytherapy)
- Recent myocardial infarction (MI) (symptom onset \</= 72 hours prior to randomization)
- CK-MB \>2x the local laboratory's upper limit of normal (ULN) (refers to a measured value on the day of the index procedure as drawn per protocol)
- Anticipated treatment with warfarin during any period in the 6 months post index procedure
- Anticipated treatment with paclitaxel, oral rapamycin or colchicine during any period in the 9 months post index procedure
- Planned use of both the study stent and a non-study stent (i.e., commercial stent) in the treatment of the target lesion
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
488 Patients enrolled
Trial Details
Trial ID
NCT00287573
Start Date
June 1 2003
End Date
January 1 2010
Last Update
August 6 2010
Active Locations (42)
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1
Baptist Medical Center Princeton
Birmingham, Alabama, United States, 35211
2
Scripps Green Hospital
La Jolla, California, United States, 92037
3
Mercy General Hospital
Sacramento, California, United States, 95819
4
Stanford Medical Center
Stanford, California, United States, 94305