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.
Studienübersicht
Status
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Sr. VP Regulatory Affairs - AngioInsight
- Telefonnummer: 16122675004
- E-Mail: gzaeska@angioinsight.com
Studieren Sie die Kontaktsicherung
- Name: Project Manager - Cardiovascular Research Foundation
- E-Mail: jungarten@crf.org
Studienorte
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California
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Palo Alto, California, Vereinigte Staaten, 94304
- Stanford University
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Hauptermittler:
- William Fearon, MD
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Kontakt:
- Archana Verma, MD
- Telefonnummer: 650-497-6299
- E-Mail: varchana@stanford.edu
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Palo Alto, California, Vereinigte Staaten, 94304
- Palo Alto Veterans Administration Hospital
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Hauptermittler:
- William Fearon, MD
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Kontakt:
- Calvert Lee
- Telefonnummer: 650-239-2808
- E-Mail: CLee@pavir.org
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District of Columbia
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Washington D.C., District of Columbia, Vereinigte Staaten, 20010
- Washington Hospital Center
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Hauptermittler:
- Hayder Hashim, MD
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Kontakt:
- Eric Suchanec
- Telefonnummer: 202-877-7207
- E-Mail: eric.suchanec@medstar.net
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Minnesota
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Minneapolis, Minnesota, Vereinigte Staaten, 55407
- Minneapolis Heart
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Kontakt:
- Bavana Rangan
- Telefonnummer: 612-863-3852
- E-Mail: Bavana.Rangan@allina.com
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Hauptermittler:
- Yader Sandoval, MD
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New Jersey
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Paramus, New Jersey, Vereinigte Staaten, 07652
- Valley Health System
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Kontakt:
- Kimberly Michel
- Telefonnummer: 201-447-8453
- E-Mail: KMICHEL@Valleyhealth.com
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Hauptermittler:
- Rajiv Tayal, MD
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New York
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New York, New York, Vereinigte Staaten, 10016
- New York University
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Hauptermittler:
- Nathaniel Smilowitz, MD
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Kontakt:
- Manuela Plazas Montana
- Telefonnummer: 917-921-6436
- E-Mail: Manuela.PlazasMontana@nyulangone.org
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New York, New York, Vereinigte Staaten, 10075
- Northwell Health
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Kontakt:
- Virgenmina Lugaro
- Telefonnummer: 212-434-6626
- E-Mail: VLugaro@northwell.edu
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Hauptermittler:
- Michael C Kim, MD
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Ohio
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Cincinnati, Ohio, Vereinigte Staaten, 45219
- Christ Hospital
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Hauptermittler:
- Tim Henry, MD
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Kontakt:
- Rebecca Harper
- Telefonnummer: 513-585-2000
- E-Mail: RebeccaM.Harper@thechristhospital.com
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Tennessee
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Nashville, Tennessee, Vereinigte Staaten, 37205
- Ascension Saint Thomas
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Hauptermittler:
- Jimmy Kerrigan, MD
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Kontakt:
- Amelia Drennan
- Telefonnummer: 615-222-3815
- E-Mail: amelia.drennan@ascension.org
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
Cohort 1
Patients with intermediate coronary artery stenosis with clinically indicated invasive FFR assessment
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Cohort 1. Patients with intermediate coronary artery stenosis (30-90% diameter stenosis) with clinically indicated FFR assessment.
|
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Cohort 2
Symptomatic patients with non-obstructive coronary artery disease (NOCAD) with clinical indication for invasive coronary microvascular assessment
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Cohort 2: Patients with non-obstructive (<30% stenosis) disease will undergo assessment of the microcirculation with bolus and continuous thermodilution.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
To establish the diagnostic performance of the AngioAI+ System
Zeitfenster: June 2026 to December 2027
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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
Zeitfenster: 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
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Carlos Collet, MD, PhD, Cardiovascular Research Foundation; OLV Aalst
- Hauptermittler: Todd C Villines, MD, University of Virginia
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CSP-001
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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