Clinical Research Trials

Key Trial Criteria

• Key Inclusion Criteria

  For a patient to be eligible for participation in this study, all of the following criteria must apply.

  • Age ≥18 years
  • Patient provides written informed consent
  • Scheduled for clinically indicated coronary catheterization with the intent to perform physiologic assessment to guide physician clinical course (in lesions with visual % diameter stenosis 40-90%), if clinically indicated
  • Subject is undergoing invasive FFR with Adenosine (high-dose intra-coronary (IC) [200 μg for the left and or 100 μg for the right coronary artery] or 140 μg/kg/min for intravenous (IV)) used as hyperemic stimulus
  • Clinical presentation with or history of stable angina, unstable angina, or silent ischemia (defined as abnormal stress test or abnormal invasive physiology assessment) that has led to the procedure

• Key Exclusion Criteria

  A patient will not be eligible for participation in this study if any of the following criteria apply.

  • Prior history of myocardial infarction (MI) in the target vessel
  • Presence of acute ST Elevation Myocardial Infarction (STEMI)
  • Culprit vessel of Non-ST Elevation Myocardial Infarction (NSTEMI)
  • TIMI flow < Grade 3 at baseline or visible thrombus
  • Prior history of coronary artery bypass grafting (CABG)
  • Prior heart transplant
  • Severe valvular heart disease or history of valve repair or replacement
  • Prior history of PCI with stent in target vessel, or target vessel involves in-stent restenosis.
  • Target coronary vessel is supplied by major collaterals or is supplying major collaterals to a CTO (chronic total occlusion)
  • CTO in the target vessel
  • Severe diffuse disease observed in target vessel defined as the presence of diffuse, serial gross luminal irregularities present in the majority of the coronary tree
  • Presence of myocardial bridge (MB), regardless of vessel location
  • Contraindication for FFR examination or administration of vasodilators
  • Known LVEF ≤45%
  • Target lesion involves Left Main coronary artery or ostial right coronary artery
  • Known renal insufficiency (eGFR < 30 ml/kg/m^2 or serum creatinine ≥ 2.5 mg/dL) unless patient is on dialysis
  • Heart Failure NYHA Class III or IV
  • Subject is pregnant (For a female subject of childbearing potential, a pregnancy test must be performed within 14 days (≤14 days) prior to the index procedure per site standard test)
  • Subject has or had active COVID-19 symptoms and/or a positive test result within the prior 2 months
  • Participation in another clinical study of an investigational drug or device
  • Presence of aneurysm in the target vessel

  Imaging and Pressure Tracing Exclusion Criteria:

  • Artifact in pre-PCI OCT for the target lesion or in the event of multiple target lesions, artifact in pre-PCI OCT for ALL target lesions
  • Target lesion requires any preparation (including but not limited to balloon dilatation, atherectomy, etc.) prior to pre-PCI OCT and physiology measurement, or in case of multiple target lesions, ALL target lesions require-any preparation (including but not limited to balloon dilatation, atherectomy, etc.) prior to pre-PCI OCT and physiology measurement
  • Severe vessel tortuosity or calcification in the target vessel such that it is unlikely that the OCT catheter can be delivered
  • Target lesion not imaged by OCT or in the event of multiple target lesions, ALL target lesions not imaged by OCT
  • Pressure drift of > 0.03; i.e. Pd and Pa ratio value < 0.97 or > 1.03, unless physiology measurements are repeated after re-equalization
  • Target lesion or significant CAD beyond 60mm from coronary ostium; i.e. not able to clearly image and capture all disease segment with OCT in 1 run
  • Incorrectly done or unsuccessful catheter purge and/or contrast flush
  • Presence of plaque rupture and/or intravascular hematoma in target vessel (visual % diameter stenosis ≥ 40%)
  • Inability to receive intracoronary nitroglycerin prior to OCT or FFR
  • Use of flush media other than radiographic contrast