Study of the Xience V Everolimus-eluting Stent in Saphenous Vein Graft Lesions (SOS-Xience V)
Prospective Evaluation of the Xience V Everolimus-Eluting Stent In Saphenous Vein Graft Atherosclerosis: The Stenting Of Saphenous Vein Grafts Xience V Angiographic Study (SOS-Xience V)
研究概览
详细说明
Implantation of bare metal coronary stents (BMS) is currently the preferred percutaneous treatment for aortocoronary saphenous vein bypass graft (SVG) lesions, but is associated with high risk for in-stent restenosis. Although drug-eluting stents (DES) appear promising, there are limited and conflicting data on their efficacy and safety in SVGs. Our group recently completed and reported the results of the SOS (Stenting Of Saphenous vein grafts) trial that compared a paclitaxel-eluting stent with a similar BMS. There is currently no data on the use of the second generation DES in these challenging lesions. The SOS-Xience V study will examine the effects of the Xience V everolimus-eluting stent in SVG lesions.
The specific aim of SOS-Xience V is to examine the 12-month incidence of binary angiographic in-stent restenosis (defined as a stenosis of > 50% of the minimum lumen diameter of the target segment) after implantation of the Xience V stent in SVG lesions.
The Xience V stent will be implanted in 40 consecutive patients who need stenting of a SVG lesion. Patients will undergo repeat follow-up angiography and intravascular ultrasonography at 12 months and will be followed clinically for 12 months to determine:
- the incidence of binary angiographic in-stent restenosis, as assessed by 12 month follow-up quantitative coronary angiography (primary study endpoint), and
- intra-stent intimal hyperplasia volume accumulation at 12 months, as measured by intravascular ultrasonography, and (b) 12-month incidence of ischemia-driven target vessel revascularization, stent thrombosis, and target vessel failure (composite of cardiac death, myocardial infarction, and target vessel revascularization) (secondary study endpoints), and (c) percent stent strut coverage by optical coherence tomography
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Texas
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Dallas、Texas、美国、75216
- VA North Texas Healthcare System
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age > 18 years
- Need for percutaneous coronary intervention of a 50-99% de novo SVG lesion that is between 2.5 and 4.5 mm in diameter, is ≤ 22 mm in length, and can be treated with implantation of a single stent
- Use of an embolic protection device during the SVG intervention
- Able and willing to return for angiographic follow-up after 12 months
- Agree to participate and provide informed consent
Exclusion Criteria:
- Use of stents other than the Xience V stent
- Planned non-cardiac surgery within the following 12 months
- Presentation with an ST-segment elevation acute myocardial infarction
- Any previous percutaneous treatment of the target lesion (with balloon angioplasty, stent, intravascular brachytherapy etc)
- Any previous percutaneous treatment of the target vessel (of a lesion different than the target lesion) within the prior 12 months
- Hemorrhagic diatheses, or refusal to receive blood transfusions
- Current treatment with warfarin
- Recent positive pregnancy test, breast-feeding, or possibility of a future pregnancy
- Coexisting conditions that limit life expectancy to less than 12 months
- Patients who have a creatinine above 2.5 mg/dL (unless they require hemodialysis, in which case they are eligible to participate)
- Patients allergic to contrast material that can not be adequately premedicated
- History of an allergic reaction or significant sensitivity to everolimus
- Documented left ventricular ejection fraction (LVEF) < 25% at most recent evaluation
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Xience V
Implantation of the Xience V stent in saphenous vein graft lesions
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The Xience V stent will be implanted in aortocoronary saphenous vein bypass graft lesions
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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 |
|---|---|
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the incidence of binary angiographic in-stent restenosis, as assessed by 12 month follow-up quantitative coronary angiography
大体时间：12 months
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12 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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intra-stent intimal hyperplasia volume accumulation at 12 months, as measured by intravascular ultrasonography
大体时间：12 months
|
12 months
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incidence of ischemia-driven target vessel revascularization, stent thrombosis, and target vessel failure (composite of cardiac death, myocardial infarction, and target vessel revascularization)
大体时间：12 months
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12 months
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Percent stent strut coverage by optical coherence tomography
大体时间：12 months
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12 months
|
合作者和调查者
调查人员
- 首席研究员：Emmanouil S Brilakis, MD, PhD、North Texas Veterans Healthcare System
- 研究主任：Subhash Banerjee, MD、North Texas Veterans Healthcare System
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
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.
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