Combined Pressure and Flow Measurements to Guide Treatment of Coronary Stenoses (DEFINE-FLOW)

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Fractional Flow Reserve, Myocardial, Coronary Flow Reserve Read More

Inclusion Criteria:

• Age ≥ 18 years.
• Eligible for PCI based on local practice standards during the current procedure (PCI cannot be staged).

• At least one epicardial stenosis of ≥50% diameter (by visual or quantitative assessment) and meeting the following criteria as determined by the operator based on either a prior or the current diagnostic angiogram:

  • <100% diameter (not a chronic, total occlusion);
  • in a native coronary artery (including side branches but excludes bypass grafts);
  • of ≥2.5mm reference diameter (near the level of the stenosis);
  • and supplies sufficiently viable myocardium (exclude regions of known, prior, transmural myocardial infarction).
• Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

• Anatomic exclusions:

  • Prior CABG.
  • Preferred treatment strategy for revascularization would be CABG based on local practice standards.
  • Left main coronary artery disease requiring revascularization.
  • Extremely tortuous or calcified coronary arteries precluding intracoronary physiologic measurements. Operators may also exclude subtotal or similar high-grade lesions, which in their judgment may be threatened by ComboWire placement.
  • Known severe LV hypertrophy (septal wall thickness at echocardiography of >13 mm).

• Clinical exclusions:

  • Inability to receive intravenous adenosine (for example, severe reactive airway disease, marked hypotension, or high-grade AV block without pacemaker).
  • Recent (within 3 weeks prior to cardiac catheterization) ST-segment elevation myocardial infarction (STEMI) in any arterial distribution (not specifically target lesion).
  • Culprit lesions (based on clinical judgment of the operator) for either STEMI or non-STEMI cannot be included.
  • Severe cardiomyopathy (LV ejection fraction <30%).
  • Planned need for cardiac surgery (for example, valve surgery, treatment of aortic aneurysm, or septal myomectomy).

• General exclusions:

  • A life expectancy of less than 2 years.
  • Inability to sign an informed consent, due to any mental condition that renders the subject unable to understand the nature, scope, and possible consequences of the trial or due to mental retardation or language barrier.
  • Potential for non-compliance towards the requirements for follow-up visits.
  • Participation or planned participation in another cardiovascular clinical trial before completing the 24 month follow-up.