Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW Study (SMARTFLOW)
Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW (SMARTFLOW) Study
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.
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Sr. VP Regulatory Affairs - AngioInsight
- 电话号码：16122675004
- 邮箱：gzaeska@angioinsight.com
研究联系人备份
- 姓名：Project Manager - Cardiovascular Research Foundation
- 邮箱：jungarten@crf.org
学习地点
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California
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Palo Alto、California、美国、94304
- Stanford University
-
首席研究员：
- William Fearon, MD
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接触：
- Archana Verma, MD
- 电话号码：650-497-6299
- 邮箱：varchana@stanford.edu
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Palo Alto、California、美国、94304
- Palo Alto Veterans Administration Hospital
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首席研究员：
- William Fearon, MD
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接触：
- Calvert Lee
- 电话号码：650-239-2808
- 邮箱：CLee@pavir.org
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District of Columbia
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Washington D.C.、District of Columbia、美国、20010
- Washington Hospital Center
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首席研究员：
- Hayder Hashim, MD
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接触：
- Eric Suchanec
- 电话号码：202-877-7207
- 邮箱：eric.suchanec@medstar.net
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Minnesota
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Minneapolis、Minnesota、美国、55407
- Minneapolis Heart
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接触：
- Bavana Rangan
- 电话号码：612-863-3852
- 邮箱：Bavana.Rangan@allina.com
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首席研究员：
- Yader Sandoval, MD
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New Jersey
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Paramus、New Jersey、美国、07652
- Valley Health System
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接触：
- Kimberly Michel
- 电话号码：201-447-8453
- 邮箱：KMICHEL@Valleyhealth.com
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首席研究员：
- Rajiv Tayal, MD
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New York
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New York、New York、美国、10016
- New York University
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首席研究员：
- Nathaniel Smilowitz, MD
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接触：
- Manuela Plazas Montana
- 电话号码：917-921-6436
- 邮箱：Manuela.PlazasMontana@nyulangone.org
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New York、New York、美国、10075
- Northwell Health
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接触：
- Virgenmina Lugaro
- 电话号码：212-434-6626
- 邮箱：VLugaro@northwell.edu
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首席研究员：
- Michael C Kim, MD
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Ohio
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Cincinnati、Ohio、美国、45219
- Christ Hospital
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首席研究员：
- Tim Henry, MD
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接触：
- Rebecca Harper
- 电话号码：513-585-2000
- 邮箱：RebeccaM.Harper@thechristhospital.com
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Tennessee
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Nashville、Tennessee、美国、37205
- Ascension Saint Thomas
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首席研究员：
- Jimmy Kerrigan, MD
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接触：
- Amelia Drennan
- 电话号码：615-222-3815
- 邮箱：amelia.drennan@ascension.org
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Cohort 1
Patients with intermediate coronary artery stenosis with clinically indicated invasive FFR assessment
|
Cohort 1. Patients with intermediate coronary artery stenosis (30-90% diameter stenosis) with clinically indicated FFR assessment.
|
|
Cohort 2
Symptomatic patients with non-obstructive coronary artery disease (NOCAD) with clinical indication for invasive coronary microvascular assessment
|
Cohort 2: Patients with non-obstructive (<30% stenosis) disease will undergo assessment of the microcirculation with bolus and continuous thermodilution.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
To establish the diagnostic performance of the AngioAI+ System
大体时间：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.
|
June 2026 to December 2027
|
|
To establish the diagnostic performance of AngioAI+ System
大体时间：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.
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June 2026 to December 2027
|
合作者和调查者
赞助
调查人员
- 首席研究员：Carlos Collet, MD, PhD、Cardiovascular Research Foundation; OLV Aalst
- 首席研究员：Todd C Villines, MD、University of Virginia
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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