A Post-market, Multi-vessel Evaluation of the Imaging of Peripheral Arteries for Diagnostic Purposes Comparing Optical Coherence Tomography and Intravascular Ultrasound Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Visualization of Vessel Morphology: Calcification
研究概览
简要总结
A non inferiority trial to determine the capability of optical coherence tomography (OCT) imaging to show vessel morphology in comparison to imaging provided by intravascular ultrasound imaging (IVUS).
详细描述
Patients requiring diagnostic imaging of peripheral vessels to determine vessel condition and planning treatment strategy will have vessel segments imaged by both OCT and IVUS imaging catheters. The images will be collected into a library and independent readers will rank each image on the quality of vessel morphology and disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •suspected vascular disease that might be a candidate for IVUS
- •reference vessel can accommodate imaging catheters
- •successful diagnostic imaging and removal of IVUS catheter with no adverse events
排除标准
- •if female, pregnant or breast-feeding
- •unwilling to give informed consent
结局指标
主要结局
Visualization of Vessel Morphology: Calcification
时间窗: During the diagnostic imaging procedures, up to 5 minutes
The primary endpoint was met when OCT imaging had the equivalent or lower mean score than IVUS imaging when comparing images for calcification. Images were scored on a scale from 1 to 5. A lower score means better image quality and a higher score means worse image quality. Scoring Scale for image quality for calcification: 1- Excellent histology-like image quality to 5- Unacceptably poor image quality.
Freedom From Adverse Events
时间窗: On day of diagnostic imaging procedures, up to 1 hour
Primary safety endpoint is freedom from diagnostic imaging procedure-related and device-associated adverse events.
Visualization of Vessel Morphology: Layered Structure
时间窗: During the diagnostic imaging procedures, up to 5 minutes
The primary endpoint was met when OCT imaging had the equivalent or lower mean score than IVUS imaging when comparing layered structures. Images were scored on a scale from 1 to 4. A lower score means better image quality and a higher score means worse image quality. Scoring Scale for image quality of layered structure: 1. clear differentiation of vessel wall layers; 2. differentiation of 3 wall layers; 3. differentiation of 2 wall layers; 4. no differentiation visible
Visualization of Vessel Morphology: Stent Structure
时间窗: During the diagnostic imaging procedures, up to 5 minutes
The primary endpoint was met when OCT imaging had the equivalent or lower mean score than IVUS imaging when comparing stent structure. Images were scored on a scale from 1 to 3. A lower score means better image quality and a higher score means worse image quality. Scoring Scale for image quality of Stent Structure: 1. Excellent image; 2. Acceptable image: 3. Unacceptably poor image.
Visualization of Vessel Morphology: Non-layered Structure
时间窗: During the diagnostic imaging procedures, up to 5 minutes
The primary endpoint was met when OCT imaging had the equivalent or lower mean score than IVUS imaging when comparing non-layered structures. Images were scored on a scale from 1 to 5. A lower score means better image quality and a higher score means worse image quality. Scoring scale for image quality of non-layered structure: 1-Excellent histology-like image quality to 5-unacceptably poor image quality
Visualization of Vessel Morphology: Artifacts
时间窗: During the diagnostic imaging procedures, up to 5 minutes
The primary endpoint was met when OCT imaging had the equivalent or lower mean score than IVUS imaging when comparing imaging artifacts. Images were scored on a scale from 1 to 3. A lower score means better image quality and a higher score means worse image quality. Scoring Scale for image quality of artifacts: 1. None; 2. Tolerable/not limiting; 3. Is intense and limits image quality.
次要结局
- Vessel Measurement: Mean Diameter(During the diagnostic imaging procedures, up to 5 minutes)
- Vessel Measurement: Total Luminal Area(During the diagnostic imaging procedures, up to 5 minutes)