Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stent in the Treatment of In-Stent Restenosis

Exclusion Criteria

• •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