Simultaneous Measurement of EpicArdial and Microvascular ResisTance via Angiographic FLOW Study (SMARTFLOW)

Study type

• Study topic:
  Medical device
• Study type:
  Non-interventional study
• Scope of the study:
  Method development or testing
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Case-only

Study drug and medical condition

• Medical condition to be studied:
  Stenosis

  Non-obstructive cardiomyopathy

Population studied

• Short description of the study population:
  Adult patients with acute or chronic coronary syndromes referred for invasive coronary angiography with clinically indicated physiologic assessment. Eligibility and Cohorts Adult patients with acute or chronic coronary syndromes referred for invasive coronary angiography with clinically indicated physiologic assessment. All patients will undergo clinically indicated invasive coronary angiography with physiological assessment according to Standard of Care (SoC).; Two prospective cohorts will be included:; 1. Cohort 1. Patients with intermediate coronary artery stenosis (30-90% diameter stenosis) with clinically indicated FFR assessment.; 2. Cohort 2. Symptomatic patients with NOCAD (<30% stenosis) with clinically indicated microvascular; assessment.; ; ; Clinical Exclusion Criteria: (1) Patients presenting with ST-elevation acute coronary syndrome, (2) Prior myocardial infarction in the target vessel, (3) Stent implantation in the target vessel within the last 12 months, (4) Previous coronary artery bypass grafting (CABG), (5) Previous heart valve surgery, (6) Previous heart transplantation, (7) Moderate-to-severe valvular disease, (8) Left ventricular ejection fraction (EF) ≤45%, (9) Hemodynamic instability or cardiogenic shock.; ; Angiographic Exclusion Criteria: (a) Left main stenosis ≥50%, (b) Chronic total occlusion in target vessel, (c) CTO in a non-target vessel, (d) Less than thrombolysis in myocardial infarction (TIMI) 3 flow in target vessel, (e) Target vessel receiving collaterals, (f) Inadequate coronary angiographic images (g) Ostial lesions, (h) Severe tortuosity.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
• Estimated number of subjects:
  650

Study design details

• Study design:
  The SMARTFLOW study is a prospective, observational, single-arm, multicentric, and international study with centralized data collection. Angiographic and physiological data will be analyzed in a blinded fashion by an independent core laboratory.
• Main study objective:
  The SMARTFLOW study aims to determine the accuracy of a novel angiography-based software AngioAI+ (developed by AngioInsight Inc.), for assessing FFR and CMD. By validating this technology against invasive physiological measurements, we seek to establish its role as a reliable, noninvasive device which aids in the comprehensive evaluation of coronary physiology assessment. The ability to assess both epicardial and microvascular function using a single imaging modality could dramatically improve diagnostic accuracy, therapeutic guidance, and overall patient outcomes.
• Setting:
  Qualified clinicians within the catheterization lab to provide an assessment of stenosis and blood flow.
• Comparators:
  Single arm, prospective study of imaging.
• Outcomes:
  Primary endpoints 1 - FFR: Per-vessel diagnostic performance (i.e., sensitivity and specificity) of AngioAI+ FFR for identifying flow-limiting lesions, using measured FFR as the reference standard.; Primary endpoints 2- CMD: Diagnostic performance (i.e., sensitivity and specificity) of AngioAI+ for detecting CMD in patients with non-obstructive CAD (NOCAD) using invasive coronary flow reserve (CFR) derived from continuous thermodilution as reference.
• Data analysis plan:
  The study is powered to demonstrate the diagnostic accuracy of AngioAI+ with a pre-defined performance goal of ≥80% sensitivity and specificity for diagnosing hemodynamically significant artery stenosis using FFR (cut-off ≤ 0.80) as reference. Assuming a sensitivity of 90%, a one-sided alpha of 0.025, and 90% power, 137 vessels with a positive FFR must be included to ensure that the lower limit of the two-sided 95% confidence interval for sensitivity is ≥80%. Assuming a specificity of 90%, a one-sided alpha of 0.025, and 90% power, 137 vessels without a positive FFR must be included to ensure that the lower limit of the two-sided 95% confidence interval for specificity is ≥80%.