Post Marketing Clinical Trial to Demonstrate the Performance of the MedHub AutocathFFR Device.
试验速览
- 阶段
- 不适用
- 发起方
- Medhub Ltd.
- 入组人数
- 488
- 主要终点
- Sensitivity and specificity
研究概览
简要总结
Patients with suspected coronary artery disease who are scheduled to undergo a coronary angiography procedure will be enrolled in the study. The angiographic images will be processed by the Medhub Autocath FFR device to generate the Autocath FFR measurement. Based on AMAR approval, MedHub Autocath FFR measurements may be used to determine revascularization in lesions found in the Left Anterior Descending (LAD) coronary artery. Consequently, invasive FFR (using a coronary pressure wire and hyperemic stimulus) is not mandatory for lesions in the LAD, although it is at the discretion of the physician whether or not to perform the invasive FFR procedure. Lesions in the Right Coronary Artery (RCA) and Left Circumflex Coronary (LCX) arteries, when clinically indicated, will be required to undergo an invasive FFR procedure in order to determine revascularization. In these cases, the Autocath FFR measurements will not be used for diagnostic or clinical decisions, but solely as a supportive tool. The MedHub Autocath FFR measurement per vessel will be compared to the invasive FFR measurement in the RCA and LCX lesions and in LAD lesions, for which invasive FFR measurements are available.
The dichotomously scored MedHub Autocath FFR per vessel will be compared to the invasive FFR, where an FFR ≤ 0.80 will be considered "positive", while an FFR > 0.8 will be considered "negative". The sensitivity and specificity of the MedHub Autocath FFR will be calculated.
详细描述
The proposed study is designed to assess performance and safety data for the MedHub Autocath FFR device.
The study is a prospective, multi-center, single-arm, post-marketing study. A total of 488 subjects will be enrolled in the study. The study population who represent the target population for this procedure consists of subjects with known or suspected coronary artery disease (CAD) who are scheduled to undergo a coronary angiography procedure and on whom invasive FFR will be measured in vessels with meaningful coronary lesions. Patients of both genders, all ethnicities, >18 years of age will be recruited to the study. Study subjects will be enrolled from numerous hospitals in Israel.
Investigators will screen subjects based on the inclusion/exclusion criteria described below. General patient demographics, medical history, concomitant medications, C-arm angiography system used, FFR pressure wire used, etc., will be obtained for study subject.
Subjects with known or suspected coronary artery disease who are scheduled for clinically indicated invasive coronary angiography will comprise the patient population. Coronary angiography will be performed in a routine fashion in patients with suspected coronary artery disease. The collected diagnostic angiography images will be processed using the Medhub Autocath FFR device to generate the Autocath FFR. Based on operator's discretion, the location of the stenosis and when clinically indicated, invasive FFR will be measured using a coronary pressure wire and hyperemic stimulus.
The patient's angiographic images will be processed using the MedHub Autocath FFR device. Based on AMAR approval, MedHub Autocath FFR measurements may be used to determine revascularization in lesions found in the Left Anterior Descending (LAD) coronary artery. Consequently, invasive FFR will not be mandatory for lesions in the LAD, and it will be at the discretion of the physician whether or not to perform the invasive FFR procedure. Lesions in the Right Coronary Anterior (RCA) and Left Circumflex (LCX) arteries, when clinically indicated, will be required to undergo an invasive FFR procedure in order to determine revascularization. That is, in these cases the MedHub Autocath FFR measurements will not be used for diagnostic or clinical decisions, but solely as a supportive tool. The MedHub Autocath FFR measurement per vessel will be compared to the invasive FFR measurement in the RCA and LCX lesions and in LAD lesions, for which invasive FFR measurements are available.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Age > 18 years.
- •Subjects with suspected coronary artery disease who are scheduled to undergo a coronary angiography procedure.
- •Subject is planned to undergo an invasive FFR with IV or intracoronary Adenosine, Adenosine Triphosphate (ATP) or Papaverine used as hyperemic stimulus*.
- •Not mandatory for lesions in the LAD
排除标准
- •Vessel size less than 2 mm.
- •CTO in target vessel.
- •Prior CABG, heart transplant or valve surgery, prior TAVI/TAVR or severe left sided valvular disease.
- •TIMI Grade 2 or lower.
- •Target lesion involves Left Main (stenosis >50%).
- •Severe, diffuse disease defined as the presence of diffuse, serial gross luminal irregularities present in the majority of the coronary tree.
结局指标
主要结局
Sensitivity and specificity
时间窗: Immediate after procedure
Co-primary endpoints are the sensitivity and specificity of the dichotomously scored MedHub Autocath FFR per vessel compared to invasive FFR, where an FFR ≤ 0.80 is scored "positive", while an FFR \> 0.8 is considered "negative".
次要结局
未报告次要终点