European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction - The OCTOBER Trial -
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,201
- 试验地点
- 74
- 主要终点
- Combined endpoint of major adverse cardiac events (MACE)
研究概览
简要总结
The purpose is to compare median two-year clinical outcome after OCT guided vs. standard guided revascularization of patients requiring complex bifurcation stent implantation
详细描述
Coronary bifurcation lesions with stenosis in a large side branch may require complex stent implantation techniques with an elevated risk of suboptimal treatment results. Intra vascular optical coherence tomography (OCT) enables improved procedural control of correctable factors and may lead to optimized implantation results.
It is unknown if routine, systematic use of OCT scans during complex bifurcation stenting improves clinical outcome but present available evidence indicates advantages of OCT guidance that could translate into improved clinical outcome.
Hypothesis
Systematic OCT guided revascularization of patients with bifurcation lesions requiring complex stent implantation provides superior two-year clinical outcome compared to standard revascularization by PCI.
Methods: Investigator initiated and investigator sponsored, randomized (1:1), controlled, prospective, multicenter, superiority trial. Randomization is stratified for 1) Left main or non-Left main artery disease, and 2) up-front planned one-stent technique with kissing balloon inflation, or a two-stent technique.
Systematic OCT guidance is detailed for five complex stent implantation techniques. Standard treatment is angiographic based with optional use of intravascular ultrasound (IVUS).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable angina pectoris, unstable angina pectoris, clinically stable non-STEMI.
- •Age ≥18 yrs.
- •Abel to provide written Informed consent and willing to comply with the specified follow-up contacts.
- •Angiographic inclusion criteria:
- •Native coronary bifurcation de novo lesion
- •More than 50% diameter stenosis in the main vessel (MV)
- •More than 50% diameter stenosis in the side branch (SB) within 5 mm of the ostium.
- •Reference size at least 2.75 mm in the main vessel (MV) and ≥2.5 mm in the SB.
- •Functional inclusion criteria:
- •Functional significance of the main vessel lesion or documented ischemia of the main vessel territory or other objective documentation of lesion significance. Objective evidence of ischemia is required for all treated lesions except for lesions with more than 80% diameter stenosis that may be considered significant.
- •Procedural inclusion criteria:
- •Indication for two-stent technique or one-stent technique with kissing balloon inflation
排除标准
- •STEMI within 72 hours
- •Cardiogenic shock
- •Prior coronary artery bypass grafting (CABG) or planned CABG
- •Renal failure with glomerular filtration rate (GFR) <50 mL/min per 1.73 m2
- •Active bleeding or coagulopathy
- •Life expectancy < 2 years
- •Ejection fraction < 30%
- •New York Heart Association (NYHA) class > II
- •Relevant allergies (aspirin, clopidogrel, ticagrelor, contrast compounds, everolimus).
- •Angiographic exclusion criteria:
- •Severe tortuosity around target bifurcation
- •Chronic total occlusions
- •Massive thrombus in Left main coronary artery
- •Medina 0.0.1 lesions
研究组 & 干预措施
Angiographic guided PCI
Angiographic guided PCI is revascularization by percutaneous coronary intervention (PCI) and optional use of intravascular ultrasound (IVUS).
干预措施: Angiographic guided PCI (Procedure)
OCT guided PCI
OCT guided PCI is percutaneous coronary intervention (PCI) guided by systematic use of intravascular optical coherence tomography (OCT)
干预措施: OCT guided PCI (Procedure)
结局指标
主要结局
Combined endpoint of major adverse cardiac events (MACE)
时间窗: 24 months
Composite of cardiac death, target lesion myocardial infarction, ischaemic driven target lesion revascularization
次要结局
- Any revascularisation(60 months)
- Post-PCI minimal lumen diameter in the side branch vessel edge segment(1 day)
- Target bifurcation myocardial infarction(60 months)
- Study bifurcation oriented composite endpoint(60 months)
- Stent Thrombosis(60 months)
- Post-PCI minimal lumen diameter in the stented proximal main vessel segment(1 day)
- Post-PCI minimal lumen diameter in the stented distal main vessel ostium segment(1 day)
- Post-PCI diameter stenosis in the stented proximal main vessel segment(1 day)
- Target lesion myocardial infarction(60 months)
- Target lesion revascularisation(60 months)
- Post-PCI minimal lumen diameter in the treated side branch vessel segment(1 day)
- Post-PCI minimal lumen diameter in the stented bifurcation core segment(1 day)
- Post-PCI diameter stenosis in non-bifurcation target distal edge segment(1 day)
- Patient oriented composite endpoint(60 months)
- Cardiac death(60 months)
- Myocardial infarction(60 months)
- Target vessel revascularisation(60 months)
- CCS angina class(60 months)
- Post-PCI minimal lumen diameter in the proximal main vessel edge segment(1 day)
- Post-PCI diameter stenosis in the stented distal main vessel segment(1 day)
- Post-PCI diameter stenosis in the treated side branch vessel segment(1 day)
- Post-PCI diameter stenosis in the stented bifurcation core segment(1 day)
- Post-PCI diameter stenosis in the treated side branch ostium segment(1 day)
- Post-PCI minimal lumen diameter in non-bifurcation target stented segment(1 day)
- Post-PCI diameter stenosis in non-bifurcation target stented segment(1 day)
- All-cause mortality(120 months)
- Target bifurcation revascularisation(60 months)
- Post-PCI minimal lumen diameter in the stented distal main vessel segment(1 day)
- Post-PCI minimal lumen diameter in the distal main vessel edge segment(1 day)
- Post-PCI minimal lumen diameter in the treated side branch vessel ostium segment(1 day)
- Post-PCI diameter stenosis in the proximal main vessel edge segment(1 day)
- Post-PCI diameter stenosis in the side branch vessel edge segment(1 day)
- Post-PCI minimal lumen diameter in non-bifurcation target distal edge segment(1 day)
- Post-PCI diameter stenosis in the distal main vessel edge segment(1 day)
- Post-PCI diameter stenosis in the stented distal main vessel ostium segment(1 day)
- Post-PCI minimal lumen diameter in non-bifurcation target proximal edge segment(1 day)
- Post-PCI diameter stenosis in non-bifurcation target proximal edge segment(1 day)
研究者
Evald Hoej Christiansen
MD, phd
Aarhus University Hospital Skejby