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临床试验/NCT01979744
NCT01979744已完成不适用

Intravascular ULTrasound Guided Versus Conventional Angiography Guided Strategy to Deploy Zotarolimus and Everolimus Eluting Third Generation Stents in the Long Coronary Artery Lesions: ULTRA-ZET Trial

Yonsei University2 个研究点 分布在 2 个国家目标入组 568 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
568
试验地点
2
主要终点
Efficacy of angiography or IVUS guided third generation stent implantation

研究概览

简要总结

Although first generation DES reduced instent restenosis, still remained the unsolved problems such as stent thrombosis and restenosis in the era of DES. Second generation DES had been developed to improve the biocompatibility of stent coating focused on polymer compared to first generation DES, so that second generation stents showed better outcomes compared with first generation DES. On the other hands, in third generation DES, further refinement of DES involved more flexible stent platform. Promus ElementTM (Everolimus eluting stent, Boston Scientific, Nastick, MA) and Resolute Integrity® (Zotarolimus eluting stent, Medtronic Vascular, Santa Rosa, CA) are the third generation drug eluting stents which are designed to increase flexibility. In previous randomized controlled studies, both of these stents have shown at least non-inferior angiographic and clinical outcomes compared to second generation DES. However, there is lack of data about comparison of angiographic and clinical outcomes between Promus ElementTM and Resolute Integrity®.

IVUS is one of the widely used intracoronary imaging devices to provide more reproducible and accurate information about coronary anatomy than angiography in current practice.8 Optimal stent expansion assessed by intravascular ultrasound (IVUS) has been reported as an important factor to prevent stent thrombosis or restenosis.9 Accordingly, there have been many studies to evaluate the procedural or clinical benefit of IVUS guided angioplasty. However, The clinical benefit of IVUS-guided angioplasty with stent implantation is still in a controversy. In the previous studies, IVUS-guided stent implantation showed positive or negative beneficial effect on clinical outcomes according to their study subjects. However, the stents used in the previous studies are less useful in current practice of cardiology and there is lack of data of 3rd generation DES, which have different stent profiles and outcomes with their predecessors.

Thus we would perform a prospective randomized study in order to compare the efficacy of IVUS-guided angioplasty with conventional angioplasty-guided procedure in the long coronary lesion. Our main hypothesis is IVUS-guided 3rd generation DES implantation in the long coronary lesions would have better clinical outcomes compared with conventional angiography-guided strategy. We also intend to assess the clinical outcomes after Promus ElementTM and Resolute Integrity® implantation.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients ≥ 19 years old
  • Coronary artery disease and lesions which are candidate for treatment with drug eluting stent according to current clinical practice guidelines
  • PCI for lesion(s) which needs a stent of 26mm or more
  • Reference diameter from 2.25 to 4.0mm

排除标准

  • Restenosis lesion
  • Reference vessel diameter < 2.25 mm or > 4.0mm
  • Primary PCI for STEMI
  • Contraindication to anti-platelet agents
  • Treated with any DES within 3 months at other vessel
  • Severe hepatic dysfunction (3 times normal reference values)
  • Pregnant women or women with potential childbearing
  • Life expectancy < 1 year

结局指标

主要结局

Efficacy of angiography or IVUS guided third generation stent implantation

时间窗: 1 year after implantation

MACEs including cardiovascular death, myocardial infarction, stent thrombosis, and target vessel revascularization

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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