A Prospective, Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stent in the Treatment of In-Stent Restenosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 488
- 试验地点
- 82
- 主要终点
- Rate of Target Vessel Revascularization
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%
排除标准
- •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
结局指标
主要结局
Rate of Target Vessel Revascularization
时间窗: 9 Months
次要结局
- Incidence of composite major adverse cardiac events (MACE) and the individual components of MACE(assessed at discharge, 1, 4 and 9 months post index procedure and annually for 5 years)
- Stent thrombosis rate(5 Years)
- Target Vessel Failure (TVF, defined as any ischemia-driven revascularization of the target vessel, MI related to the target vessel, or death related to the target vessel).(5 Years)
- Clinical procedural success and technical success(5 Years)
- Binary restenosis rate(5 years)
- Evaluate outcomes and treatment of recurrent restenosis in the TAXUS stent arm(5 Years)
- Absolute lesion length(9 Months)
- Reference Vessel Diameter (RVD)(9 Months)
- Minimum Lumen Diameter (MLD)(9 Months)
- Percent diameter stenosis (% DS)(9 Months)
- Acute gain(9 Months)
- Late loss(9 Months)
- Loss index(9 Months)
- Patterns of recurrent restenosis, including edge effect(9 Months)
- Coronary aneurysm(9 Months)
- Identification of potential safety issues.(9 Months)
- Change in neointimal volume from post procedure to follow-up(9 Months)
- Change in MLD within the stent or area of brachytherapy(9 Months)
- Minimum lumen area (MLA) within the stent or area of brachytherapy(9 Months)
- Lumen, plaque and vessel measurements at the treatment edges (outside of the stent or area of brachytherapy)(9 Months)