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SMARTFLOWNCT07676097

Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW Study

StatusEnrolling by Invitation
PhaseNot specified
Primary completion (estimated)
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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Enrolling by invitation only Show 4 more changesShow less
    • Trial sites expanded: 9 → 14 locations
    • Start date changed from estimate of Jun 2026 to Jul 28, 2026
    • Eligibility criteria expanded, about 20 words
    • Study description revised
  2. Primary endpoint(s) modifiedv2
  3. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

To establish the diagnostic performance of the AngioAI+ System
Timeframe: June 2026 to December 2027
To establish the diagnostic performance of AngioAI+ System
Timeframe: June 2026 to December 2027

Arms and interventions

Cohort 1

Patients with intermediate coronary artery stenosis with clinically indicated invasive FFR assessment

Cohort 2

Symptomatic patients with non-obstructive coronary artery disease (NOCAD) with clinical indication for invasive coronary microvascular assessment

Procedures: Patients with intermediate coronary artery stenosis with clinically indicated FFR assessment., Microvascular assessment

Sites

14 sites in 2 countries

United States 10, United Kingdom 4