Sirolimus-Eluting Stent vs. Intravascular Brachytherapy in In-Stent Restenotic Coronary Artery Lesions(SISR)
A Multicenter, Randomized Study of the Sirolimus-Eluting Bx VELOCITY® BALLOON Expandable Stent vs. Intravascular Brachytherapy in the Treatment of Patients With In-Stent Restenotic Coronary Artery Lesions
研究概览
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Minnesota
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Rochester、Minnesota、美国、55905
- Mayo Clinic Rochester
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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:
1. The patient has an in-stent restenosis of > 50% (by subjective angiographic determination of the minimal luminal diameter compared to the distal reference diameter) within a native coronary artery which has previously undergone stent placement ( 4 weeks). Lesions must meet ISR Classification I-III.
2. The patient has a history, signs of, or laboratory studies that suggest coronary ischemia attributable to the target stenosis. The diagnosis of angina pectoris is defined by Canadian Cardiovascular Society Classification (CCS I, II, III, or IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II) OR patients with documented silent ischemia;
3. The study target lesion must be located in an in-stent restenotic native coronary artery measuring > 2.75mm and 3.5mm in diameter and > 15mm and 40mm in length to allow treatment with a maximum of three 18mm stents. The target lesion must have undergone coronary interventional treatment > 4 weeks previously. Patients with one or more prior percutaneous coronary interventions at the target lesion are acceptable candidates.
4. The vessel 1cm distal to the target lesion is > 2.5mm in diameter;
5. Ejection Fraction must be > 40%;
6. The study target lesion cannot be located in a vessel containing a second lesion requiring treatment at the time of the procedure.
7. Male or non-pregnant female patients > 18 years of age inclusive. NOTE: Females of child-bearing potential must have a negative pregnancy test (urine or serum) prior to enrollment and must use birth control for 6 months.
Exclusion Criteria:
- The study target lesion has definite or possible thrombus present by angiographic criteria.
- The patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK > 2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remain above normal at the time of treatment.
- Impaired renal function (Serum creatinine > 2.0mg/dl);
- The patient has unstable angina classified as Braunwald III B or C, or is having peri infarction angina.
- The left ventricular ejection fraction is < 40%.
- The target vessel has previously sustained a perforation.
- Totally occluded vessel (TIMI 0 level);
- Prior stent within 5mm of target lesion;
- There is a total occlusion of the restenosed-stent (ISR Classification IV) prior to the interventional procedure.
- Has an ostial target lesion;
- Significant (> 50%) in-stent restenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
学习计划
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:1个
密码 Bx 速度
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Sirolimus-Eluting Bx Velocity® Balloon Expandable Stent
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有源比较器:2
Brachytherapy
|
Brachytherapy
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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 |
---|---|
Target vessel failure (TVF) defined as cardiac death, myocardial infarction, or target vessel revascularization at 9 months post-procedure.
大体时间:9 months post-procedure.
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9 months post-procedure.
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次要结果测量
结果测量 |
大体时间 |
---|---|
术后 6 个月和 9 个月的靶病变血运重建 (TLR)。
大体时间:手术后 6 个月和 9 个月
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手术后 6 个月和 9 个月
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术后 6 个月和 9 个月的靶血管血运重建 (TVR)。
大体时间:手术后 6 个月和 9 个月
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手术后 6 个月和 9 个月
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Angiographic in-lesion and in-stent binary restenosis (³ 50% diameter stenosis) at 6 months post-procedure (by QCA).
大体时间:6 months post-procedure
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6 months post-procedure
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Post-procedure and six-month in-stent and in-lesion percent diameter stenosis (%DS) and late loss at 6 months post-procedure (by QCA) - [analysis at 6 months chosen so that results from the GAMMA Trial can be used].
大体时间:6 months post-procedure
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6 months post-procedure
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Post-procedure and six-month in-stent and in-lesion minimum lumen diameter (MLD) (by QCA).
大体时间:Post-procedure and at six-month
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Post-procedure and at six-month
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Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization at 30 days and 6, 9, and 12-months, and 2, 3, 4, and 5 years post-proce
大体时间:30 days and 6, 9, and 12-months, and 2, 3, 4, and 5 years post-procedure
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30 days and 6, 9, and 12-months, and 2, 3, 4, and 5 years post-procedure
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Stent lumen and stent obstruction volume by intravascular ultrasound (IVUS) at post-procedure and six months in a subset of patients conducted at 5-7 investigational centers.
大体时间:post-procedure and six months
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post-procedure and six months
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Cost associated with the index hospitalization, length of stay, and repeat hospitalizations during the 12 mo post-procedure follow-up.
大体时间:12 mo post-procedure
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12 mo post-procedure
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Rate of late thrombosis
大体时间:Throughout study
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Throughout study
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合作者和调查者
调查人员
- 首席研究员:David R. Holmes, Jr., MD、Mayo Clinic - Rochester, Minnesota
出版物和有用的链接
一般刊物
- Holmes DR Jr, Teirstein P, Satler L, Sketch M, O'Malley J, Popma JJ, Kuntz RE, Fitzgerald PJ, Wang H, Caramanica E, Cohen SA; SISR Investigators. Sirolimus-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the SISR randomized trial. JAMA. 2006 Mar 15;295(11):1264-73. doi: 10.1001/jama.295.11.1264. Epub 2006 Mar 12.
- Holmes DR Jr, Teirstein PS, Satler L, Sketch MH Jr, Popma JJ, Mauri L, Wang HP, Schleckser PA, Cohen SA; SISR Investigators. 3-year follow-up of the SISR (Sirolimus-Eluting Stents Versus Vascular Brachytherapy for In-Stent Restenosis) trial. JACC Cardiovasc Interv. 2008 Aug;1(4):439-48. doi: 10.1016/j.jcin.2008.05.010.
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
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