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.
Studieoversikt
Status
Detaljert 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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Sr. VP Regulatory Affairs - AngioInsight
- Telefonnummer: 16122675004
- E-post: gzaeska@angioinsight.com
Studer Kontakt Backup
- Navn: Project Manager - Cardiovascular Research Foundation
- E-post: jungarten@crf.org
Studiesteder
-
-
California
-
Palo Alto, California, Forente stater, 94304
- Stanford University
-
Hovedetterforsker:
- William Fearon, MD
-
Ta kontakt med:
- Archana Verma, MD
- Telefonnummer: 650-497-6299
- E-post: varchana@stanford.edu
-
Palo Alto, California, Forente stater, 94304
- Palo Alto Veterans Administration Hospital
-
Hovedetterforsker:
- William Fearon, MD
-
Ta kontakt med:
- Calvert Lee
- Telefonnummer: 650-239-2808
- E-post: CLee@pavir.org
-
-
District of Columbia
-
Washington D.C., District of Columbia, Forente stater, 20010
- Washington Hospital Center
-
Hovedetterforsker:
- Hayder Hashim, MD
-
Ta kontakt med:
- Eric Suchanec
- Telefonnummer: 202-877-7207
- E-post: eric.suchanec@medstar.net
-
-
Minnesota
-
Minneapolis, Minnesota, Forente stater, 55407
- Minneapolis Heart
-
Ta kontakt med:
- Bavana Rangan
- Telefonnummer: 612-863-3852
- E-post: Bavana.Rangan@allina.com
-
Hovedetterforsker:
- Yader Sandoval, MD
-
-
New Jersey
-
Paramus, New Jersey, Forente stater, 07652
- Valley Health System
-
Ta kontakt med:
- Kimberly Michel
- Telefonnummer: 201-447-8453
- E-post: KMICHEL@Valleyhealth.com
-
Hovedetterforsker:
- Rajiv Tayal, MD
-
-
New York
-
New York, New York, Forente stater, 10016
- New York University
-
Hovedetterforsker:
- Nathaniel Smilowitz, MD
-
Ta kontakt med:
- Manuela Plazas Montana
- Telefonnummer: 917-921-6436
- E-post: Manuela.PlazasMontana@nyulangone.org
-
New York, New York, Forente stater, 10075
- Northwell Health
-
Ta kontakt med:
- Virgenmina Lugaro
- Telefonnummer: 212-434-6626
- E-post: VLugaro@northwell.edu
-
Hovedetterforsker:
- Michael C Kim, MD
-
-
Ohio
-
Cincinnati, Ohio, Forente stater, 45219
- Christ Hospital
-
Hovedetterforsker:
- Tim Henry, MD
-
Ta kontakt med:
- Rebecca Harper
- Telefonnummer: 513-585-2000
- E-post: RebeccaM.Harper@thechristhospital.com
-
-
Tennessee
-
Nashville, Tennessee, Forente stater, 37205
- Ascension Saint Thomas
-
Hovedetterforsker:
- Jimmy Kerrigan, MD
-
Ta kontakt med:
- Amelia Drennan
- Telefonnummer: 615-222-3815
- E-post: amelia.drennan@ascension.org
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
To establish the diagnostic performance of the AngioAI+ System
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Carlos Collet, MD, PhD, Cardiovascular Research Foundation; OLV Aalst
- Hovedetterforsker: Todd C Villines, MD, University of Virginia
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CSP-001
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .