Last updated on June 2020

Functional Assessment by Virtual Online Reconstruction. The FAVOR III Europe Japan Study

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Coronary Artery Disease | Coronary heart disease
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Age of 18 years and above
  • Both genders
  • Indication for invasive coronary angiography
  • Patients with stable angina pectoris, or assessment of secondary lesions in stabilized non-STEMI patients or assessment of secondary lesions in patients with prior STEMI and staged evaluation of secondary lesions.
  • Able to provide written informed consent

Angiographic inclusion criteria

  • Diameter stenosis of 40-90% diameter stenosis
  • Vessel diameter of at least 2.5 mm and supplying viable myocardium
  • Patients with restenosis in a native coronary artery can be included

Exclusion Criteria:

  • Severely impaired renal function: Glomerular filtration rate (GFR) < 20 mL/min/1.73m
  • Life expectancy less than one year
  • Cardiogenic shock or unstable haemodynamic state (Killip class III and IV)
  • ST-elevation myocardial infarction (STEMI) within 72 hours
  • Bypass graft to any target vessel
  • Atrial fibrillation at the time of the procedure
  • Chronic total occlusions of any vessel with possible or established indication for treatment
  • Pregnancy or intention to become pregnant during the course of the trial
  • Breast feeding
  • Planned need for concomitant valvular or aortic surgery
  • Left ventricular ejection fraction (LVEF) < 30%
  • Previous inclusion in the FAVOR III trial
  • Enrolled in another clinical study, and for this reason not treated according to present European Society of Cardiology guidelines, or the protocol treatment conflicts with the protocol treatment of FAVOR III
  • Inability to tolerate contrast media
  • Inability to tolerate Adenosine

Angiographic exclusion criteria

  • Ostial right coronary artery > 50% diameter stenosis
  • Left main coronary artery > 50% diameter stenosis
  • Lesions properties indicative of myocardial bridging
  • Bifurcation lesions with major (>1 mm) step down in reference size across the bifurcation
  • Severe tortuosity of any target vessel
  • Severe overlap in the stenosed segment
  • Poor image quality precluding identification of vessel contours

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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