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.
Studieoversigt
Status
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Sr. VP Regulatory Affairs - AngioInsight
- Telefonnummer: 16122675004
- E-mail: gzaeska@angioinsight.com
Undersøgelse Kontakt Backup
- Navn: Project Manager - Cardiovascular Research Foundation
- E-mail: jungarten@crf.org
Studiesteder
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California
-
Palo Alto, California, Forenede Stater, 94304
- Stanford University
-
Ledende efterforsker:
- William Fearon, MD
-
Kontakt:
- Archana Verma, MD
- Telefonnummer: 650-497-6299
- E-mail: varchana@stanford.edu
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Palo Alto, California, Forenede Stater, 94304
- Palo Alto Veterans Administration Hospital
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Ledende efterforsker:
- 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, Forenede Stater, 20010
- Washington Hospital Center
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Ledende efterforsker:
- 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, Forenede Stater, 55407
- Minneapolis Heart
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Kontakt:
- Bavana Rangan
- Telefonnummer: 612-863-3852
- E-mail: Bavana.Rangan@allina.com
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Ledende efterforsker:
- Yader Sandoval, MD
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New Jersey
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Paramus, New Jersey, Forenede Stater, 07652
- Valley Health System
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Kontakt:
- Kimberly Michel
- Telefonnummer: 201-447-8453
- E-mail: KMICHEL@Valleyhealth.com
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Ledende efterforsker:
- Rajiv Tayal, MD
-
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New York
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New York, New York, Forenede Stater, 10016
- New York University
-
Ledende efterforsker:
- Nathaniel Smilowitz, MD
-
Kontakt:
- Manuela Plazas Montana
- Telefonnummer: 917-921-6436
- E-mail: Manuela.PlazasMontana@nyulangone.org
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New York, New York, Forenede Stater, 10075
- Northwell Health
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Kontakt:
- Virgenmina Lugaro
- Telefonnummer: 212-434-6626
- E-mail: VLugaro@northwell.edu
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Ledende efterforsker:
- Michael C Kim, MD
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45219
- Christ Hospital
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Ledende efterforsker:
- 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, Forenede Stater, 37205
- Ascension Saint Thomas
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Ledende efterforsker:
- Jimmy Kerrigan, MD
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Kontakt:
- Amelia Drennan
- Telefonnummer: 615-222-3815
- E-mail: amelia.drennan@ascension.org
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
To establish the diagnostic performance of the AngioAI+ System
Tidsramme: June 2026 to December 2027
|
|
June 2026 to December 2027
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Carlos Collet, MD, PhD, Cardiovascular Research Foundation; OLV Aalst
- Ledende efterforsker: Todd C Villines, MD, University of Virginia
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CSP-001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret enhedsprodukt
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