跳至主要内容
临床试验/NCT02894697
NCT02894697终止不适用

Clinical Significance of Pre-interventional Optical Coherence Tomography in Bioresorbable Vascular Scaffold Implantation

Yonsei University2 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2016年9月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
123
试验地点
2
主要终点
An incidence of OCT-defined suboptimization of BVS requiring additional BVS

研究概览

简要总结

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. However, there is still no sufficient evidence that OCT has an inevitable role in optimal implantation of BVS and it should be more evaluated in real practice. In the study, the investigators will evaluate an incidence of OCT-defined BVS sub-optimization requiring additional PCI+A1.

详细描述

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. However, there is still no sufficient evidence that OCT has an inevitable role in optimal implantation of BVS and it should be more evaluated in real practice. In the study, the investigators will evaluate an incidence of OCT-defined BVS sub-optimization requiring additional PCI+A1.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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 ≤ 28 mm
  • Reference vessel diameter of 2.5 to 3.5 mm by operator assessment

排除标准

  • Complex lesion morphologies such as aorto-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, and restenosis
  • Contraindication or hypersensitivity to anti-platelet agents or contrast media
  • 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 understand or read the informed content

研究组 & 干预措施

Angiography-guidance

Active Comparator

干预措施: Angiography-guided PCI with BVS (Device)

OCT-guidance

Experimental

干预措施: Optical coherence tomography-guided PCI with BVS (Device)

结局指标

主要结局

An incidence of OCT-defined suboptimization of BVS requiring additional BVS

时间窗: 1 second after angiographic scaffold optimization is obtained

An incidence of OCT-defined BVS suboptimization requiring additional PCI : A composite of minimal scaffold area \<5 mm2, residual area stenosis \>20%, major edge dissections, incomplete strut apposition and scaffold pattern disruptions

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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