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

Study summary

Study identification

• EU PAS number:
  EUPAS1000001032
• Study ID:
  1000001032
• Official title and acronym:
  Simultaneous Measurement of EpicArdial and Microvascular ResisTance via Angiographic FLOW Study (SMARTFLOW)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  France

  United Kingdom

  United States
• Study description:
  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 evaluate performance of the AngioAI+ software in a retrospective manner. The investigational AngioAI+ device will not inform clinical decisions amid the study.; ; Primary endpoint 1 – FFR; Primary endpoint 2- CMD.; ; 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.; </30%; stenosis)></30%; stenosis)>
• Study status:
  Planned

Research institutions and networks

Institutions

Toulouse University Hospital

Guy's and St Thomas' NHS Foundation Trust

Cardiovascular Center OLV Aalst, Belgium

Study timelines

Date when funding contract was signed

Planned:01/07/2026

Study start date

Planned:01/07/2026

Data analysis start date

Planned:01/08/2027

Date of final study report

Planned:01/01/2028

Sources of funding

Other

More details on funding

Sponsor is a for-profit corporation in the United States.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)