Clinical Evaluation of A New High-speed and High-resolution Intravascular Ultrasound System: A Multi-center Prospective Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 5
- 主要终点
- Mean Stent Area in square millimeter(MSA)
研究概览
简要总结
Insight Lifetech Intravascular Ultrasound Diagnostic System (referred to as Insight Lifetech IVUS system below),is a new high-speed and high-resolution device for clearly defining vessel architecture and plaque morphology, providing quantitative and qualitative assessment of coronary arteries. Besides, IVUS has already an established role in guidance and optimization of percutaneous coronary intervention. This study will compare the differences, if any, between the intravascular ultrasound(IVUS) results measured by the two different IVUS diagnostic systems.
详细描述
Many studies have reported that IVUS is an accurate method for determining the size of the target vessel undergoing stent implantation , and the optimal stent deployment (complete stent expansion and apposition and lack of edge dissection or other complications after implantation). The novel 60 megahertz(60MHz) high-definition IVUS has evolved as a next-generation IVUS imaging technology to provide higher image resolution than conventional 40 megahertz(40MHz) IVUS but with sufficient imaging depth preserved for the assessment of the entire vessel wall structure.
Insight Lifetech IVUS system includes TrueVision IVUS diagnostic catheter and VivoHeart IVUS diagnostic console. It is a novel device with high speed, high resolution, and high image acquisition rate enabling high-speed pullback imaging up to 10mm/sec.
This study is a prospective, multi-center, randomized, single-blind, controlled study with the primary target of investigating the differences, if any, between IVUS measurement results by the Insight Lifetech IVUS system and Boston Scientific IVUS system, imaging catheter of which was available at 40MHz during the study. Other purposes included analyzing the feasibility of the Insight Lifetech IVUS system's high-speed pullback during the IVUS assessment. A total of 130 patients will be recruited from 5 centers in China.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Age: 18 Years and older;
- •Understand and willing to sign the informed consent form;
- •Clinical evaluation shows that the coronary artery stent implantation and the intravascular ultrasound(IVUS) guidance is required.
排除标准
- •Unable to understand or unwilling to sign the informed consent form;
- •Clinically diagnosed with severe coronary artery spasms;
- •Contraindicated to percutaneous coronary intervention (PCI);
- •Presence of any other factor that the investigator deems is unsuitable for enrollment or completion of this study.
结局指标
主要结局
Mean Stent Area in square millimeter(MSA)
时间窗: estimated 1 month on average, by a third-party corelab IVUS image post-analysis
Comparison between the MSA measured by the Insight Lifetech Intravascular Ultrasound Diagnositic System and Boston Scientific Intravascular Ultrasound Diagnostic System, including mean relative deviation, confidence interval and standard deviation, as assessed by Bland-Altman analysis and Pearson correlation analysis.
次要结局
- Clear Stent Length in millimeter (CSL)(estimated 1 month on average, by a third-party corelab IVUS image post-analysis)
- Minimal Lumen Area in square millimeter(MLA)(estimated 1 month on average, by a third-party corelab IVUS image post-analysis)
- The rate of detected stent malapposition, tissue prolapse and dissection(estimated 1 month on average, by a third-party corelab IVUS image post-analysis)
- Stability of system (questionnaire)(estimated 1week on average, by opeartor's rating on questionaire)
- Maneuvering performance of catheter (questionnaire)(estimated 1week on average, by opeartor's rating on questionaire)
- Device success rate(estimated 1day on average, by intraoperative monitoring)
- Rate of device-related adverse effects(estimated 1day on average, by intraoperative monitoring)
- Rate of thrombosis, diffuse lesion and re-stenosis as discerned by IVUS(estimated 1 month on average, by a third-party corelab IVUS image post-analysis)
- Rate of plaque rupture and plaque properties as discerned by IVUS(estimated 1 month on average, by a third-party corelab IVUS image post-analysis)