NCT01255956Unknown3 期
Efficacy Evaluation of In-bare Metal Stent Restenosis Treatment With Rapamycin Eluting Stent or Paclitaxel Eluting Balloon Catheter. Study With Intravascular Ultrasound and Optical Coherence Tomography
Medical University of Warsaw8 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2010年12月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- Incidence of repeated restenosis angiographically evidenced
研究概览
简要总结
The aim of the study is to compare rapamycin eluting stent and paclitaxel eluting balloon catheter in the treatment of restenosis in bare metal stent.
详细描述
Study aims:
- Clinical efficacy evaluation of different treatment's strategies, including periprocedural and long-term endpoints defined as: death, myocardial infarction, brain stroke, necessity of repeated revascularization
- Evaluation of intravascular ultrasound (IVUS) as an optimisation method for direct and long-term revascularization effects
- Evaluation of optical coherence tomography as an optimisation method for direct and long-term revascularization effects
- Evaluation of late lumen loss and neointimal hyperplasia in stent in long-term follow-up
- Analysis of direct and indirect medical costs of alternative treatment strategies
Study group:
200 patients with symptomatic restenosis evidenced angiographically in bare metal stent implanted in native coronary artery. Patients will be randomised to 2 therapeutic groups:
- Patients treated with rapamycin eluting stent (n=100)
- Patients treated with paclitaxel eluting balloon catheter (n=100)
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
- •at least 18 years of age
- •symptomatic restenosis in bare metal stent implanted in native coronary artery
- •angina pectoris
- •ischemia evidenced by non-invasive diagnostic tests
- •angiographically evidenced in-stent restenosis > 50% assessed by quantitative coronary angiography (QCA)
- •vessel diameter > 2,5 mm
排除标准
- •myocardial infarction within less than past 72 hours
- •heart failure with left ventricular ejection fraction (LVEF) < 30%
- •chronic renal failure with significant impairment of glomerular filtration (creatinine > 2 mg/dl)
- •hypersensitivity or contraindication to acetylsalicylic acid, clopidogrel, heparin, abciximab, rapamycin, paclitaxel
- •hypersensitivity to contrast
- •other diseases that may cause significant deterioration in long-term prognosis
- •acute or chronic inflammatory diseases
- •patients who are unwilling to consent for participation in the study
- •Angiographic exclusion criteria:
- •significant stenosis in left main coronary artery (LM)
- •multivessel disease qualifying for coronary artery bypass grafting (CABG)
- •anatomical localization and morphology that preclude optimal percutaneous intervention intervention's (PCI) result or intravascular ultrasound (IVUS) or optical coherence tomography performance
- •vessel diameter < 2,5 mm
- •restenotic lesion length > 30 mm
结局指标
主要结局
Incidence of repeated restenosis angiographically evidenced
时间窗: at 9 months
Neointimal volume assessed by intravascular ultrasound (IVUS)
时间窗: at 9 months
Late lumen loss and neointimal volume assessed by optical coherence tomography (OCT)
时间窗: at 9 months
次要结局
- Incidence of repeated target lesion revascularization (TLR)(at 9 months)
- Incidence of repeated target vessel revascularization (TVR)(at 9 months)
- Incidence of death(at 9 months)
- Incidence of myocardial infarction(at 9 months)
- Incidence of brain stroke(at 9 months)
- Incidence of in-stent thrombosis(at 9 months)
研究者
研究点 (8)
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