A Randomized, Parallel, Active Controlled Study to Evaluate the Vascular Response of Orsiro vs. Xience Drug Eluting Stent System in Subjects With Coronary Bifurcation Lesions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Percentage of stent strut coverage at bifurcation segments
研究概览
简要总结
This study aims to compare vessel response and clinical outcomes of a biodegradable-polymer, ultra-thin strut, drug-eluting stent (Orsiro, Biotronik) and a durable-polymer, thin-strut, drug-eluting stent (Xience, Abbott) for the treatment of coronary bifurcation lesions with two-stent double-kissing crush technique. How the differences in stent platforms affect vessel healing process will be examined by optical coherence tomography.
详细描述
Patients with true coronary bifurcation lesions (Medina [1, 1, 1] or [0, 1, 1]) will be enrolled and randomized to undergo two-stent double kissing crush technique with Orsiro or Xience. Pre-intervention and post-stenting optical coherence tomography will be performed during the index procedure. Another parallel prospective registry will enroll patients with bifurcation lesions treated with provisional one-stent strategy. All subjects will receive coronary angiography and optical coherence tomography follow-up at 3 and 12 months.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are at least 20 years old and present with acute or chronic coronary syndrome.
- •Patients who are suitable for PCI with DES implantation and provide written informed consent.
- •Patients with coronary bifurcation lesion amenable to be treated with 2-stent double-kissing (DK) crush technique.
- •Target vessels suitable for OCT examination.
- •Women of childbearing potential must have a negative pregnancy (serum and/or urine) test within 7 days prior to index procedure in accordance with the institutional standard of care. Female subjects who are surgically sterile or post-menopausal are exempt from having a pregnancy test.
排除标准
- •Patient who are not suitable candidates for use of dual antiplatelet therapy (DAPT)
- •Estimated glomerular filtration rate < 45 ml/min/1.73 m2
- •Liver cirrhosis
- •Life expectancy < 1 year
- •Planned surgery within 3 months
- •Pregnancy, breast-feeding, or plan to be pregnant in the coming 12 months
- •Target bifurcation lesion involved in chronic total occlusion or the culprit vessel of ST-elevation myocardial infarction
结局指标
主要结局
Percentage of stent strut coverage at bifurcation segments
时间窗: 3 months post-procedure
次要结局
- In-stent late-lumen loss by quantitative coronary analysis(3 months post-procedure)
- Target Lesion Revascularization (TLR)(12 months post-procedure)
- Target Vessel Revascularization (TVR)(12 months post-procedure)
- Stent thrombosis(12 months post-procedure)
- Amount of in-segment intimal hyperplasia (mm3) at bifurcation segments(12 months post-procedure)
- Percentage of stent strut coverage at bifurcation segments(12 months post-procedure)
- Major Cardiac Adverse Events (MACE)(12 months post-procedure)
- Neointimal thickness (μm) at bifurcation segments(12 months post-procedure)
- In-segment late lumen loss by quantitative coronary analysis(12 months post-procedure)
- Target Lesion Failure (TLF)(12 months post-procedure)
- Amount of in-stent intimal hyperplasia (mm3) at bifurcation segments(12 months post-procedure)
- Percentage of acquired malapposed struts at bifurcation segments(12 months post-procedure)
- Instent late-lumen loss by quantitative coronary analysis(12 months post-procedure)
研究者
Ying-Chang Tung
Assistant Professor, Department of Cardiology
Chang Gung Memorial Hospital