Last updated on December 2019

Radiographic Imaging Validation and EvALuation for Angio iFR (ReVEAL iFR)

Are you eligible to participate in this study?

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

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

Inclusion Criteria:

  1. 18 years old
  2. At least 1 de-novo lesion in 1 or more major epicardial vessels of 40-90% angiographic stenosis with a reference vessel size 2.5mm in the diseased segment by visual estimate
  3. Able and willing to provide informed consent

Exclusion Criteria:

  1. Presenting with an acute coronary syndrome (ACS), or documented ACS within 4 weeks prior to the scheduled index procedure
  2. Cardiogenic shock (sustained (>10 min) systolic blood pressure <90 mmHg in absence of inotropic support or the presence of an intra-aortic balloon pump)
  3. Presence of cardiac arrhythmias (e.g., atrial fibrillation, AV-block)
  4. Prior cardiac surgery or implant, including CABG, heart transplant, surgical heart valve replacement or repair, TAVI/TAVR, presence of an ICD or pacemaker
  5. Presence of any left main disease (isolated or non-isolated)
  6. Presence of any ostial right coronary artery disease (located immediately at the origin of the coronary vessels from the aorta)
  7. Any vessel with Chronic Total Occlusion (CTO)
  8. Target vessel with severe tortuosity (1 bends of 90 or more, or 3 or more bends of 45- 90 proximal to the diseased segment)
  9. Target vessel with heavy calcification (multiple persisting opacifications of the coronary wall visible in more than one projection surrounding the complete lumen of the coronary artery at the site of the lesion.)
  10. Target vessel with TIMI flow grade 1 or 0
  11. Target vessel with severe diffuse disease (more than 75% of the length of the segment having a vessel diameter of 2mm, irrespective of the presence or absence of a lesion)
  12. Target lesion is at a bifurcation/trifurcation
  13. Target arteries supplying akinetic or severely hypokinetic territories if already known based on prior imaging
  14. Target vessel is supplied by major collaterals
  15. Target stenosis associated with myocardial bridge
  16. Any vascular abnormality precluding optimal contrast opacification (e,g, thrombus, ulceration)
  17. Severe aortic or mitral valve disease
  18. Known ejection fraction 30%
  19. Known severe renal insufficiency (eGFR<30ml/min/1.72m2)
  20. Any fluoroscopic interference that renders the wire position unclear
  21. Contraindication for adenosine or other hyperemic agent (e.g., caffeine ingestion 18 hours, COPD, hypotension, AV block)
  22. Known pregnancy or planning to become pregnant
  23. Participating in another interventional investigational study

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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