A Prospective Optical Coherence Tomography Study on Completeness of Strut Coverage and Vessel Wall Response at 3-6 and 9 Months Following Paclitaxel Eluting Stent Implantation in Multivessel Coronary Artery Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Proportion of uncovered and/or malapposed Taxus Libertè struts at different time point after the implant, as measured by OCT
研究概览
简要总结
A prospective Optical Coherence Tomography (OCT) study on the completeness of strut coverage and vessel wall response, at different time points (3-6-9 Months), following TAXUS Liberte stent implantation (staged procedures) in patients with multi vessel native coronary artery lesions
详细描述
Major concerns were addressed to the delayed healing process of drug-eluting stents in off-label indications. To date no studies have detailed the in-vivo completeness of DES coverage at different time points. The objective of this prospective study is to measure the completeness of strut coverage and vessel wall response (neointima disomogeneity, acquired late incomplete strut apposition) at different time points following paclitaxel-eluting stent implantation, in patients with multivessel disease treated with staged PCI procedures. Optical Coherence Tomography (OCT) that detects smaller degrees of stent strut coverage more accurately than IVUS will be used at different time point. Intravascular ultrasound (IVUS) will be performed as per normal practice at any index procedures and 9 months elective follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Multivessel coronary artery disease (two or 3 VD) to be treated at 2 sequences (staged procedures) with paclitaxel-polymer eluting stents
- •Native coronary artery disease with >= 75% diameter stenosis
- •Vessel size in between 2.5 and 3.5 mm.
- •Written informed consent signed
排除标准
- •No suitable anatomy for OCT scan: (truly ostial , tortuous anatomy, very distal lesions or vessels larger than 3.75 in reference diameter).
- •significant left main coronary artery disease,
- •lesions in bypass grafts,
- •acute myocardial infarction,
- •poor cardiac function as defined by left ventricular ejection fraction ≤ 30%.
- •allergy to aspirin and or clopidogrel/ticlopidine,
- •Renal failure with creatinine value > 2.5 mg/dl
结局指标
主要结局
Proportion of uncovered and/or malapposed Taxus Libertè struts at different time point after the implant, as measured by OCT
时间窗: 3-6-9 months
次要结局
- % Incomplete apposition at different point of FU (3-6-9 months)(3-6-9 months)
- Proportion of neointima disomogeneity around struts at different point of FU (3-6-9 months)(3-6-9 months)
- OCT Neointima thickness overtime(3-6-9 months)
- Ischemia Driven Target Vessel Failure (ID-TVF) rate at 12 months(12 months)
- Adjudicated MACE rate at 30 days and 12 months(30 days and 12 months)