跳至主要内容
临床试验/NCT06272643
NCT06272643进行中(未招募)不适用

Comparison Between Optical Coherence Tomography and Intravascular Ultrasound for Intermediate Left Main Coronary Artery Lesions

Fundación EPIC18 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2024年4月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
153
试验地点
18
主要终点
To assess the agreement between minimum luminal area measured by IVUS and OCT in intermediate LCMA lesions

研究概览

简要总结

Significant coronary disease of the left main coronary artery (LMCA) is found in 4%-5% of all coronary angiography procedures. Classically, it has been determined that a significant angiographic stenosis should reach at least 50% of the vessel diameter by visual estimation, which corresponds to 75% of the vessel area. However, angiography has a number of limitations inherent to the technique and location of stenosis, and other techniques are therefore available for evaluation. Intracoronary ultrasound (IVUS) deserves, together with the pressure guidewire, special consideration in determining the severity assessment (anatomical and functional) of lesions in this location. Using IVUS the most commonly used cut-off value is 6 mm2. in ambiguous lesions of the LMCA, a MLA >6 mm2 would indicate no revascularisation, a MLA <4.5-5 mm2 would indicate revascularisation, and MLA values between 4.5-5 and 6 mm2 would make it advisable to use FRF/iFR to decide. Optical coherence tomography (OCT) is another intracoronary imaging modality, with greater resolution and significant differences from IVUS. no MLA cut-off point with OCT has been demonstrated for the management of LMCA lesions. Due to the differences in imaging with both techniques, the thresholds established as cut-off points in IVUS cannot be extrapolated to OCT. The objective is to compare the minimal luminal area by IVUS and OCT of angiographically intermediate LCMA lesions and to assess the prognostic value of TCFA assessed by OCT.

详细描述

Significant coronary disease of the left main coronary artery (LMCA) is found in 4%-5% of all coronary angiography procedures. It is a particularly important site, since it supplies up to 75% of myocardial blood supply, and damage at this level thus implies a large amount of left ventricular myocardium at risk, with a mortality rate close to 40% at 3 years, if revascularisation is not performed.

Anatomically, it has a number of particularities compared to the rest of the coronary arteries, such as its larger diameter (5±0.5 mm) and variable length (10.5±5.3 mm), a composition, particularly at the aorto-ostial level, more similar to the aorta than to the coronary arteries, and in up to 20-30% of the population there is also a division between the anterior descending artery (LAD) and the circumflex artery (LCx) of a third branch called the ramus intermedius or bisector branch.

Classically, it has been determined that a significant angiographic stenosis should reach at least 50% of the vessel diameter by visual estimation, which corresponds to 75% of the vessel area. However, angiography has a number of limitations inherent to the technique and location of stenosis, and other techniques are therefore available for evaluation. Intracoronary ultrasound (ICUS or IVUS) deserves, together with the pressure guidewire, special consideration in determining the severity assessment (anatomical and functional) of lesions in this location.

Several ICUV studies have attempted to find a minimum luminal area (MLA) as the cut-off point, ranging from 4.5-7.5 mm2, to decide whether to perform revascularisation or not. However, the most commonly used cut-off value is 6 mm2 for various reasons. First, it is correlated with functionally significant values using pressure guidewire. Second, the linear law is applied (assuming the fractal nature of the vasculature and a cut-off value of 3 mm2 for the LMCA branches). Finally, it has been validated by the prospective LITRE study with clinical results at 2 years of follow-up. Other studies in Asian population have proposed lower cut-off values (4.5 mm2). However, this population has different body size and therefore smaller LMCA size, the study has lower sensitivity (1/4 of patients with area >4.5 mm2 had positive pressure guidewire), and clinical validation is not presented unlike the LITRE study.

In addition to its value in diagnosis, use of ICUSE allows for optimisation of percutaneous coronary intervention (PCI) if necessary, with decreased events as compared to angiography. Therefore, current clinical practice guidelines consider the use of IVUS to stratify the severity of all LMCA lesions as an indication IIa B. In turn, it has been proposed to integrate the use of ICUS and pressure guidewire in the assessment of doubtful LMCA lesions. Thus, in ambiguous lesions of the LMCA, a MLA >6 mm2 would indicate no revascularisation, a MLA <4.5-5 mm2 would indicate revascularisation, and MLA values between 4.5-5 and 6 mm2 would make it advisable to use FRF/iFR to decide.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • •Patients aged ≥18 years
  • •Patients with intermediate lesion in the LMCA (Left Main Coronary Artery) (25-60% angiographic stenosis by visual estimation) in whom a study with intracoronary imaging technique is considered (at least one pullback with IVUS (Intravascular ultrasound) and OCT (OPTICAL COHERENCE TOMOGRAPHY) from one of the main branches is mandatory).
  • •Patients able to give informed consent form.

排除标准

  • •Patients with indication for coronary surgery regardless of significance of LMCA lesion.
  • •Patients with LMCA lesion showing ulceration, dissection or thrombus.
  • •Patients with lesion in a previous functioning arterial or venous graft in the territory supplied by the LMCA (protected LMCA).
  • •Patients with acute coronary syndrome with potentially culpable injury in LMCA.
  • •Patients unable to give informed consent.
  • •Patients with ostial LMCA lesion.

研究组 & 干预措施

Patients with Left Main Coronary Artery lesion (25-60%)

干预措施: IVUS (Intravascular Ultrasound) and OCT (Optical Coherence Tomography) (Diagnostic Test)

结局指标

主要结局

To assess the agreement between minimum luminal area measured by IVUS and OCT in intermediate LCMA lesions

时间窗: During intervention

To assess the agreement between minimum luminal area measured by IVUS and OCT in intermediate LCMA lesions in patients with PCI for MLA in ICUS \<6 mm2 and OCT without TCFA.

次要结局

  • Cardiac Death(12 months)
  • Acute myocardial infarction of treated/functionally assessed lesion(12 months)
  • Need for revascularisation of any lesion(12 months)
  • Cardiovascular Death(12 months)
  • Acute myocardial infarction of any lesion(12 months)
  • Need for revascularisation of lesion treated/functionally assessed(12 months)
  • Secondary efficacy endpoint: Clear Image Length(During intervention)
  • Extend of detectable EEL in LM(During intervention)
  • Correlation between contrast volume used and results, as well as the average contrast volume used in the study.(30 days after intervention)

研究者

发起方
Fundación EPIC
申办方类型
Other
责任方
Sponsor

研究点 (18)

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