A Comparison of Optical Coherence Tomography Guidance and Angiography-only Guidance for Percutaneous Coronary Intervention With Bioresorbable Vascular Scaffold
2016年7月26日 更新者：Yonsei University
A Randomized Controlled Comparison of Optical Coherence Tomography Guidance and Angiography-only Guidance for Percutaneous Coronary Intervention With Bioresorbable Vascular Scaffold
It is well-known that non-optimal stent implantation associated with under-expansion or incomplete strut apposition during percutaneous coronary intervention (PCI) leads to a higher incidence of restenosis and stent thrombosis.
OCT-guided PCI with metallic stent has previously been shown to be safe and feasible, resulting in better clinical outcomes compared with angiography-only guided PCI.
Everolimus-eluting bioabsorbable vascular scaffold (BVS; Abbott Vascular, Santa Clara, CA, USA) was made from a bioabsorbable polylactic acid backbone which is coated with a more rapidly absorbed polylactic acid layer that contains and controls the release of the antiproliferative drug, everolimus.
BVS has a number of proposed advantages over current metallic stent technology.
These include elimination of chronic sources of vessel irritation and inflammation, which can reduce the potential risk of late scaffold thrombosis after complete scaffold bioresorption.
Although the current generation of the Absorb BVS have larger strut thickness of 150 μm compared with 80 μm of strut of Xience stent, the acute recoil of the polymeric device was similar to that of metallic stent.
However, operators tented to use dilating devices less aggressively because of the concerns about limitation in elongation-at-break of polylactide.
Previous studies reported 20-30% of under-expansion or malapposition with BVS, which would increase the risk of adverse events including late stent thrombosis.
OCT-guidance may improve more optimized scaffold placement and also better outcomes.
Therefore, investigators will compare OCT guidance and angiography-only guidance for PCI with BVS regarding incomplete scaffold apposition and neointimal scaffold coverage.
Investigators are also going to compare these two strategies regarding clinical outcomes with verification of the cut-off value by OCT-acquired uncovered scaffold rate.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
13
阶段
- 不适用
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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Seoul、大韩民国、120-752
- Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
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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
19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:
- Patients ≥ 19 years old
- Patients with ischemic heart disease who are considered for coronary revascularization with PCI
- Significant coronary de novo lesion (stenosis > 70% by quantitative angiographic analysis) treated by single BVS ≤ 25mm
- Reference vessel diameter of 2.5 to 3.5 mm by operator assessment
Exclusion Criteria:
- Myocardial infarction
- Complex lesion morphologies such as aorta-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, and restenosis
- Reference vessel diameter <2.5 mm or >3.5 mm
- Heavy calcified lesions (definite calcified lesions on angiogram)
- Lesions requiring 2 or more BVS
- Contraindication or hypersensitivity to anti-platelet agents or contrast media
- Treated with any metallic stent or BVS within 3 months at other vessel
- Creatinine level ≥ 2.0 mg/dL or ESRD
- Severe hepatic dysfunction (3 times normal reference values)
- Pregnant women or women with potential childbearing
- Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
- Inability to understand or read the informed content
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 |
|---|---|
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有源比较器：Angiography-guidance
Everolimus-eluting bioresorbable vascular scaffold (Absorb, Abbott Vascular, Santa Clara, CA, USA) was made from a bioabsorbable polylactic acid backbone which is coated with a more rapidly absorbed polylactic acid layer that contains and controls the release of the antiproliferative drug, everolimus.
PCI will be performed with BVS under conventional coronary angiography without any other intravascular imaging modality.
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Everolimus-eluting bioresorbable vascular scaffold (Absorb, Abbott Vascular, Santa Clara, CA, USA) was made from a bioabsorbable polylactic acid backbone which is coated with a more rapidly absorbed polylactic acid layer that contains and controls the release of the antiproliferative drug, everolimus.
PCI will be performed with BVS under conventional coronary angiography without any other intravascular imaging modality.
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实验性的：OCT-guidance
Everolimus-eluting bioresorbable vascular scaffold (Absorb, Abbott Vascular, Santa Clara, CA, USA) was made from a bioabsorbable polylactic acid backbone which is coated with a more rapidly absorbed polylactic acid layer that contains and controls the release of the antiproliferative drug, everolimus.
For optimized PCI, both conventional coronary angiography and optical coherence tomography can be used before and after stent implantation.
OCT study should be checked at the final post-procedure and stent implantation is optimized.
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Everolimus-eluting bioresorbable vascular scaffold (Absorb, Abbott Vascular, Santa Clara, CA, USA) was made from a bioabsorbable polylactic acid backbone which is coated with a more rapidly absorbed polylactic acid layer that contains and controls the release of the antiproliferative drug, everolimus.
For optimized PCI, both conventional coronary angiography and optical coherence tomography can be used before and after stent implantation.
OCT study should be checked at the final post-procedure and stent implantation is optimized.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of uncovered scaffold struts
大体时间：six months
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Percentage of uncovered scaffold struts between OCT guidance vs. angiography-only guidance PCI on 6 month OCT
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six months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Major cardiac and cerebrovascular adverse events (MACCEs)
大体时间：until one year
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Cardiac death, myocardial infarction, target vessel revascularization, stent thrombosis, cerebrovascular accident and major bleeding between OCT guidance vs. angiography-only guidance PCI until 12 months *Major bleeding ; causing mortality, hypovolemic shock or severe hypotension requiring inotropes or surgery, intrapericardial with tamponade, significant disabling (e.g. intraocular bleeding leading to loss of vision), symptomatic intracranial haemorrhage, intraocular bleeding leading to loss of vision, hemoglobin drop ≥ 3g/dL, or requiring transfusion more than 2 units |
until one year
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Percentage of incomplete scaffold struts apposition
大体时间：six months after stent implantation
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Scaffold strut malapposition: Malapposition is defined by a clear seperation between the abluminal side of the strut and the vessel wall.
As a result, scaffold malapposition is defined as the presence of any malapposed struts.
percentage of malapposed struts (% malapposed strut) was the ratio of malapposed struts from total analyzable struts.
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six months after stent implantation
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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。
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
2015年6月1日
初级完成 (实际的)
2016年5月1日
研究完成 (实际的)
2016年6月1日
研究注册日期
首次提交
2015年6月3日
首先提交符合 QC 标准的
2015年6月4日
首次发布 (估计)
2015年6月9日
研究记录更新
最后更新发布 (估计)
2016年7月27日
上次提交的符合 QC 标准的更新
2016年7月26日
最后验证
2016年7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.