Assessment of Catheter-based Interrogation and Standard Techniques for Fractional Flow Reserve Measurement: the ACIST-FFR Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 240
- 试验地点
- 12
- 主要终点
- FFR Measurements
研究概览
简要总结
This study will assess the differences between Fractional Flow Reserve (FFR) measurements made by the Navvus catheter and a commercially available pressure guidewire in up to 240 subjects where FFR is clinically indicated. All subjects will receive diagnostic treatment according to clinical indications and center standard practice.
详细描述
The ACIST-FFR study is a prospective, open label, observational, multi-center study designed to assess the differences, if any, between FFR measured by the Navvus catheter and a commercially available 0.014-inch pressure guidewire (St. Jude Medical, Volcano, hereafter referred to as the PW) in subjects with coronary artery disease (CAD) undergoing coronary angiography. This will be accomplished by comparing the FFR measurement obtained with the ACIST Medical Systems RXi System and Navvus catheter with the FFR measurement obtained by using a PW within the same subject across the same target lesion at the same time.
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
- •Subject is 18 years of age or older
- •Subject has a clinical indication for coronary angiography
- •Subject or subject's legal representative has the ability to understand and provide signed consent for participating in the study
- •Angiographic Inclusion Criteria:
- •Vessel has a TIMI flow = 3
- •Subject has de novo lesion which physician has determined has a clinical indication for FFR measurement
- •RVD of the target lesion is assessed by the operator to be ≥2.25 mm.
排除标准
- •Subjects with acute ST-elevation or non-ST-elevation myocardial infarction as the indication for coronary angiography
- •NYHA Class 4 severe heart failure
- •Angiographic Exclusion Criteria:
- •Target vessel has angiographically visible or suspected thrombus.
- •Target lesion is within a bypass graft.
- •Angiographic evidence of a dissection prior to initiation of PW measurements.
- •Target vessel contains excessive tortuosity or calcification.
结局指标
主要结局
FFR Measurements
时间窗: Duration of FFR Procedure
Bias between Navvus and PW FFR measurements, as assessed by Bland-Altman analysis
次要结局
- Slope of Passing-Bablok(Duration of FFR Procedure)
- Intercept of Passing-Bablok(Duration of FFR Procedure)
- Comparability of FFR Measurements(Duration of FFR Procedure)
- Diagnostic FFR concurrence of stenosis significance(Duration of FFR Procedure)
- Device success rate(Duration of FFR Procedure)
- Mean drift(Duration of FFR Procedure)
- Rate of clinically significant drift(Duration of FFR Procedure)
- PW Pd/Pa diagnostic concurrence of stenosis signficance(Duration of FFR Procedure)
- PW Pd/Pa measurements with Navvus across and not across lesion(Duration of FFR Procedure)
- Comparison of Pd/Pa Measurements including bias(Duration of FFR Procedure)
- Rate of device-related adverse effects(Duration of FFR Procedure)
- PW FFR measurements with Navvus across and not across lesion(Duration of FFR Procedure)
- Comparison of FFR Measurements including bias(Duration of FFR Procedure)
- Correlation between Navvus diagnostic accuracy, bias, and angiographic characteristics(Duration of FFR Procedure)