Sealing Moderate Coronary Saphenous VEin Graft Lesions With Paclitaxel-Eluting Stents (VELETI II)
2016年10月26日 更新者：Josep Rodes-Cabau、Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Sealing Moderate Coronary Saphenous VEin Graft Lesions With Paclitaxel-Eluting Stents as a New Approach to MainTaining VeIn Graft Patency and Reducing Cardiac Events
Hypothesis: Sealing moderate SVG lesions with paclitaxel-eluting stents reduces cardiac events (death, myocardial infarction, target vessel revascularization) over the duration of follow-up.
Primary objective: To evaluate the efficacy of stenting moderate SVG lesions with paclitaxel-eluting stents on reducing the first occurrence of the composite of cardiac death, myocardial infarction or repeat revascularization related to the target SVG over the duration of follow-up (minimun of 2-year follow-up.
研究概览
详细说明
This is a prospective, multicenter, randomized study assessing the efficacy of stenting moderate SVG lesions (30% to 60% by visual estimation) with paclitaxel-eluting stents in the prevention of SVG atherosclerosis progression and cardiac events at follow-up.
Patients with previous coronary bypass surgery with SVG implantation undergoing coronary angiography by clinical indication will be screened.
If the patient has a moderate lesion at any level of the SVGs it will be includable in the study.
After inclusion, the patients will be randomized to either stenting the moderate SVG lesion with the taxus stent or standard medical treatment.
Following this procedure, all patients will have follow-up visits by telephone or clinic at 30 days, 180 days, 1 year, and yearly until the common study end date.
The duration of the study will be approximately 4 years with a minimun of 2-year follow-up.
研究类型
介入性
注册 (实际的)
125
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Quebec、加拿大、G1V 4G5
- Institut Universitaire de cardiologie et de pneumologie de Quebec
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Clinical indication for cardiac catheterization and SVG angiography
Presence of at least one SVG lesion of 30% to 60% diameter stenoses, by visual estimation, which is not the culprit lesion* responsible for the clinical syndrome of the patient
*If the target lesion is located in the same SVG than the culprit lesion (if present) it has to be at least 4 cm far from the stented segment)
- Written informed consent
Exclusion Criteria:
- Patient < 18 years old
- Ejection fraction < 30%
- Renal insufficiency with creatinine > 200 μmol/l
- Presence of more than 2 moderate SVG stenoses in a single SVG or significant diffuse SVG disease defined as disease covering more than half of the length of the SVG
- Presence of more than 2 SVGs with moderate SVG stenoses
- Unsuccessful angioplasty (residual stenosis >30% and/or TIMI flow <3) of any other lesion treated during the same procedure (culprit lesions will be treated before patient randomization)
- Any significant complication occurring during the angioplasty of the culprit lesion(s) during the same procedure
- SVG lesion located at the distal anastomosis
- SVG lesions located at the proximal anastomosis (lesion length < 5 mm from the SVG ostium)
- Lesion length >25 mm
- SVGs ≤ 3 years ago
- Cardiogenic shock
- Remaining coronary or SVG lesion(s) with treatment (PCI or CABG) planned within the following year
- Pregnancy
- Contraindication to aspirin and/or thienopyridine/ticagrelor treatment
- Allergy to paclitaxel
- Any disease with a limiting life-expectancy (less than 2 years)
- Need for chronic anticoagulation treatment
- Definite presence or high suspicion of thrombus or ulceration in the target lesion
- Target lesion located in the same SVG as the culprit lesion (if present) and distance between the target lesion and the most proximal or distal part of the stent implanted at the culprit lesion < 4 cm
- Vein graft diameter < 2.5 mm
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：PCI支架术
用紫杉醇支架置入中度 SVG 病变
|
患者被随机分配到使用紫杉醇支架对中度 SVG 病变进行支架植入或标准药物治疗
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无干预：Standard medical treatment
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
The first occurrence of the composite of cardiac death, myocardial infarction or coronary revascularization related to the target SVG over the duration of follow-up.
大体时间：60 months
|
60 months
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
1-First occurrence of the composite of cardiac death, myocardial infarction or coronary revascularization over the duration of follow-up.
大体时间：60 months
|
60 months
|
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2-Cardiac death and myocardial infarction; repeat revascularization; and hospitalization due to an acute coronary syndrome.
大体时间：60 months
|
60 months
|
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3-Total medical costs (at index hospitalization and at follow-up).
大体时间：60 months
|
60 months
|
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4-Costs per major adverse cardiac event (cardiac death, myocardial infarction, revascularization) prevented.
大体时间：60 months
|
60 months
|
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5-Severe (>60%) SVG lesions or SVG occlusion at the target SVG at 2-year follow-up as determined by 3D computed-tomography.
大体时间：60 months
|
60 months
|
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6-Major bleeding complications defined according to the REPLACE-II criteria over the duration of follow-up.
大体时间：60 months
|
60 months
|
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7-Stent thrombosis defined and classified according to the Academic Research Consortium criteria.
大体时间：60 months
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60 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年4月1日
初级完成 (实际的)
2015年8月1日
研究完成 (实际的)
2016年9月1日
研究注册日期
首次提交
2010年10月18日
首先提交符合 QC 标准的
2010年10月18日
首次发布 (估计)
2010年10月19日
研究记录更新
最后更新发布 (估计)
2016年10月27日
上次提交的符合 QC 标准的更新
2016年10月26日
最后验证
2016年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.