IVUS-Guided Treatment for Percutaneous Vascular Interventions
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 5,000
- 试验地点
- 5
- 主要终点
- Improve
研究概览
简要总结
The main objective of the study is to survey and improve the IVUS image quality and X-ray system interoperability by collecting Procedural Data (e.g. raw, pre- processed ultrasound and X-ray data, endpoints such as fluoroscopy time, contrast load and radiation dose, workflow details) during routine intravascular procedures to assure adherence to the high standards of quality during care delivery and promote procedural standardization.
详细描述
This is a prospective, multicenter, single-arm study to collect procedural data (e.g., raw, pre-processed IVUS, X-ray, and other procedural data) for image quality, workflow and interoperability assessments. Example of additional procedural endpoint data (e.g., time for fluoroscopy and IVUS, contrast load and radiation dose, workflow details, etc.) will be collected. The study will be conducted in a phased approach.
Since the collection of IVUS raw data with a second non-diagnostic pullback affects procedure time, the two aspects of this study - collection of raw IVUS data and procedural data, will be separated until IVUS raw data can be collected directly from the IVUS system with no additional procedural time.
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
- •The Patient is ≥18 years of age.
- •Patient is scheduled to undergo percutaneous vascular intervention - peripheral vascular or coronary PCI procedure.
排除标准
- •Patients not meeting the instructions for use (IFU) of the respective IVUS catheters.
- •Patients with lesions or vessel segments deemed unsafe for multiple IVUS pullbacks.
- •Patients who are pregnant.
结局指标
主要结局
Improve
时间窗: Procedure (one visit)
Analyze IVUS images for improvement using manual and automated visualization
次要结局
- Procedural IVUS TIME(Procedure (one visit))
- PROCEDURAL AMOUNT OF CONTRAST USED(Procedure (one visit))
- PROCEDURAL RADIATION DOSE(Procedure (one visit))