Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW (SMARTFLOW) Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 620
- 试验地点
- 9
- 主要终点
- To establish the diagnostic performance of the AngioAI+ System
研究概览
简要总结
The aim of this study is to establish the diagnostic performance of the AngioAI+ System (AngioInsight, Inc, USA) for estimating:
- Fractional flow reserve (FFR) and
- Detection of coronary microvascular disease (CMD)
SMARTFLOW is a prospective, single-arm, observational multicenter study of patients with suspected coronary artery disease (CAD) undergoing clinically indicated invasive coronary angiography with physiological assessment. The study is designed to prospectively enroll patient cohorts and collect data according to their reference procedures (e.g. FFR, CFR measures). A core lab will evaluate performance of the AngioAI+ software retrospectively using the collected SMARTFLOW study data. As such, the investigational AngioAI+ device will not inform clinical decisions amid the study procedure.
详细描述
All patients will undergo clinically indicated invasive coronary angiography with physiological assessment according to standard of care.
Cohort 1: Patients with intermediate lesions (30-90% diameter stenosis) will undergo invasive FFR assessment. In patients with FFR >0.80 (non-flow limiting stenosis), subsequent assessment of the microcirculation with bolus and continuous thermodilution will be performed.
Cohort 2: Patients with non-obstructive (<30% stenosis) disease will undergo assessment of the microcirculation with bolus and continuous thermodilution.
For patients in Cohort 1 with FFR ≤0.80 undergoing percutaneous coronary interventions (PCI), FFR measurements after PCI will be recommended. Use of intravascular imaging will be strongly encouraged to guide PCI procedures, in accordance with current practice guidelines.
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
- •Patients with acute or chronic coronary syndromes referred for invasive coronary angiography with clinically indicated coronary physiologic assessment. In patients with acute coronary syndromes, the physiological evaluation will be restricted to non-culprit vessels.
- •Patients with intermediate CAD (30-90% visual stenosis) with clinically indicated FFR assessment.
- •Patients with NOCAD (<30% visual stenosis) with clinically indicated microvascular assessment.
排除标准
- •Patients presenting with ST-elevation
- •Prior myocardial infarction in the target vessel
- •Stent implantation in the target vessel within the last 12 months
- •Previous coronary artery bypass grafting surgery (CABG)
- •Previous heart valve surgery
- •Previous heart transplantation
- •Moderate-to-severe valvular disease
- •Left ventricular ejection fraction (EF) ≤45%
- •Hemodynamic instability or cardiogenic shock
- •Angiographic Exclusion Criteria
- •Left main stenosis≥50%
- •Chronic total occlusion in the target vessel
- •CTO in a non-target vessel
- •Less than thrombolysis in myocardial infarction (TIMI) 3 flow in the target vessel
- •Target vessel receiving collaterals
- •Inadequate coronary angiographic images
- •Ostial lesions
- •Severe tortuosity
研究组 & 干预措施
Cohort 1
Patients with intermediate coronary artery stenosis with clinically indicated invasive FFR assessment
干预措施: Patients with intermediate coronary artery stenosis with clinically indicated FFR assessment. (Procedure)
Cohort 2
Symptomatic patients with non-obstructive coronary artery disease (NOCAD) with clinical indication for invasive coronary microvascular assessment
干预措施: Microvascular assessment (Procedure)
结局指标
主要结局
To establish the diagnostic performance of the AngioAI+ System
时间窗: June 2026 to December 2027
1\. Per-vessel diagnostic performance (i.e., sensitivity and specificity) of AngioAI+ FFR for identifying flow-limiting lesions, using measured FFR as the reference standard.
To establish the diagnostic performance of AngioAI+ System
时间窗: June 2026 to December 2027
Description: 2. Diagnostic performance (i.e., sensitivity and specificity) of AngioAI+ for detecting CMD in patients with non-obstructive CAD using invasive coronary flow reserve (CFR) derived from continuous thermodilution as reference.
次要结局
未报告次要终点