randomized trial evaluating slow-release formulation taxus paclitaxel-eluting coronary stent in the treatment of in-stent restenosis

Conditions: Coronary Restenosis

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 restenosis.

percutaneous approaches to in-stent restenosis (isr) have included balloon angioplasty alone, rotational atherectomy, cutting balloon angioplasty, directional coronary atherectomy, excimer laser angioplasty, placement of a second stent or any combination thereof, and intra-coronary brachytherapy. of these, only brachytherapy has been shown to reduce recurrent restenosis after pci for isr, - and is now considered the standard of care. logistical considerations in establishing and maintaining a radiation program have limited the widespread availability of this modality. these considerations include the need for involvement of radiation oncologists, physicists, and safety officers; nuclear licensing requirements; need for increased shielding and safety training; equipment and procedural complexities; as well as increased procedural time and costs. furthermore, recurrent isr after brachytherapy may still occur. stent based drug delivery for the treatment of isr holds promise as a much simpler, safer and potentially more effective alternative to brachytherapy. this is a prospective, randomized (1:1), open-label, multicenter, safety and efficacy trial for the treatment of in-stent restenosis. the primary objective is to demonstrate a superior or non-inferior 9-month target vessel revascularization (tvr) rate for taxus-sr stent compared to intra-coronary brachytherapy (beta source).

Eligibility criteria:
inclusion criteria: * 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 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