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.
Studieöversikt
Status
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Sr. VP Regulatory Affairs - AngioInsight
- Telefonnummer: 16122675004
- E-post: gzaeska@angioinsight.com
Studera Kontakt Backup
- Namn: Project Manager - Cardiovascular Research Foundation
- E-post: jungarten@crf.org
Studieorter
-
-
California
-
Palo Alto, California, Förenta staterna, 94304
- Stanford University
-
Huvudutredare:
- William Fearon, MD
-
Kontakt:
- Archana Verma, MD
- Telefonnummer: 650-497-6299
- E-post: varchana@stanford.edu
-
Palo Alto, California, Förenta staterna, 94304
- Palo Alto Veterans Administration Hospital
-
Huvudutredare:
- William Fearon, MD
-
Kontakt:
- Calvert Lee
- Telefonnummer: 650-239-2808
- E-post: CLee@pavir.org
-
-
District of Columbia
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Washington D.C., District of Columbia, Förenta staterna, 20010
- Washington Hospital Center
-
Huvudutredare:
- Hayder Hashim, MD
-
Kontakt:
- Eric Suchanec
- Telefonnummer: 202-877-7207
- E-post: eric.suchanec@medstar.net
-
-
Minnesota
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Minneapolis, Minnesota, Förenta staterna, 55407
- Minneapolis Heart
-
Kontakt:
- Bavana Rangan
- Telefonnummer: 612-863-3852
- E-post: Bavana.Rangan@allina.com
-
Huvudutredare:
- Yader Sandoval, MD
-
-
New Jersey
-
Paramus, New Jersey, Förenta staterna, 07652
- Valley Health System
-
Kontakt:
- Kimberly Michel
- Telefonnummer: 201-447-8453
- E-post: KMICHEL@Valleyhealth.com
-
Huvudutredare:
- Rajiv Tayal, MD
-
-
New York
-
New York, New York, Förenta staterna, 10016
- New York University
-
Huvudutredare:
- Nathaniel Smilowitz, MD
-
Kontakt:
- Manuela Plazas Montana
- Telefonnummer: 917-921-6436
- E-post: Manuela.PlazasMontana@nyulangone.org
-
New York, New York, Förenta staterna, 10075
- Northwell Health
-
Kontakt:
- Virgenmina Lugaro
- Telefonnummer: 212-434-6626
- E-post: VLugaro@northwell.edu
-
Huvudutredare:
- Michael C Kim, MD
-
-
Ohio
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Cincinnati, Ohio, Förenta staterna, 45219
- Christ Hospital
-
Huvudutredare:
- Tim Henry, MD
-
Kontakt:
- Rebecca Harper
- Telefonnummer: 513-585-2000
- E-post: RebeccaM.Harper@thechristhospital.com
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Tennessee
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Nashville, Tennessee, Förenta staterna, 37205
- Ascension Saint Thomas
-
Huvudutredare:
- Jimmy Kerrigan, MD
-
Kontakt:
- Amelia Drennan
- Telefonnummer: 615-222-3815
- E-post: amelia.drennan@ascension.org
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
To establish the diagnostic performance of the AngioAI+ System
Tidsram: 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
Tidsram: 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.
|
June 2026 to December 2027
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Carlos Collet, MD, PhD, Cardiovascular Research Foundation; OLV Aalst
- Huvudutredare: Todd C Villines, MD, University of Virginia
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CSP-001
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