Impact of IVUS-guided Chronic Total Occlusion InterVention With DrUg-eluting Stents on Mid-term Angiographic and Clinical Outcomes (CTO-IVUS Study)
试验速览
- 阶段
- 4 期
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- event rate of cardiac death within 12 months
研究概览
简要总结
Guidance of stenting by IVUS has been proposed as a method to reduce restenosis rates, because lumen and stent dimensions can be accurately determined by intravascular ultrasound (IVUS).
详细描述
Guidance of stenting by IVUS has been proposed as a method to reduce restenosis rates, because lumen and stent dimensions can be accurately determined by intravascular ultrasound (IVUS). However, randomized studies investigating this strategy have yielded inconsistent results. Therefore, the investigators hypothesized that the potential advantages of IVUS guidance would be most apparent in Chronic Total Occlusion (CTO) intervention and try to evaluate the impact of IVUS-guided chronic total occlusion intervention with drug-eluting stents on mid-term angiographic, IVUS and clinical outcomes.
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
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is ≥ 20 years or ≤ 80 years old
- •On coronary angiography, complete obstruction of coronary blood flow (TIMI grade 0) with estimated occlusion duration ≥ 3months.
- •On coronary angiography, Reference vessel diameter of 2.5 to 4.0mm by operator assessment
- •On coronary angiography, Total length of total occluded lesion and main lesion is less than 80mm and lesions can be treated less than 4 stents.
- •Guide wire can be passed through occluded lesion without complications
- •Patients who can keep the dual antiplatelet treatment (aspirin, clopidogrel) more than 6 months after procedure
排除标准
- •Hypersensitivity reaction or side effects to Aspirin, Clopidogrel, Biolimus A9 and Zotarolimus
- •unprotected Left main disease
- •Cardiogenic shock or LV ejection fraction ≤ 30%
- •Previous stent restenotic lesion
- •Treated within 2 weeks at the same lesion.
- •Creatinine level ≥ 2.0 mg/dL or ESRD
- •Severe tortuous and calcified lesion (Unobtainable IVUS image)
- •Life expectancy < 1 year
- •Severe hepatic dysfunction (3 times normal reference values)
- •Pregnant women or women with potential childbearing
研究组 & 干预措施
Non-IVUS guided endeavor-R group
2x2 randomization by the treatment of IVUS-guided intervention vs. Non-IVUS guided intervention and the types of the implanted DES, Endeavor-R vs. Nobori.
干预措施: Non-IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic) (Device)
IVUS guided endeavor-R group
2x2 randomization by the treatment of IVUS-guided intervention vs. Non-IVUS guided intervention and the types of the implanted DES, Endeavor-R vs. Nobori.
干预措施: IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic) (Device)
Non-IVUS guided Nobori group
2x2 randomization by the treatment of IVUS-guided intervention vs. Non-IVUS guided intervention and the types of the implanted DES, Endeavor-R vs. Nobori.
干预措施: Non-IVUS guided intervention with Nobori stent (biolimus A9-eluting stent, Terumo) (Device)
IVUS guided Nobori group
2x2 randomization by the treatment of IVUS-guided intervention vs. Non-IVUS guided intervention and the types of the implanted DES, Endeavor-R vs. Nobori.
干预措施: IVUS guided intervention with Nobori stent (biolimus A9-eluting stent, Terumo) (Device)
结局指标
主要结局
event rate of cardiac death within 12 months
时间窗: 12 months after CTO intervention.
Between IVUS guided intervention and non-IVUS guided intervention in patient with chronic total occlusion, the difference of post-procedural success rate, the combined event rate of cardiac death, MI and target lesion revascularization within 12 months. And incidence of composite events in cross over case of IVUS duing CTO intervention
次要结局
- Incidence of MACE after stent implantation.(24 months after CTO intervention)
研究者
Yangsoo Jang
Professor of cardiology
Yonsei University