The Drift-Reduction for Improved FFR Using Fiberoptic Technology (DRIFT) Study

Inclusion Criteria:

• Male or female subjects, >18 years of age.

• Patients with stable angina, unstable angina or non-ST segment elevation myocardialinfarction (if the LAD lesion is the non-culprit lesion) and in whom an intermediateproximal LAD de novo stenosis (30-80%) with TIMI flow 3 has been identified onangiography. Note: Patients with multi-vessel disease can be enrolled.

• Patients have had fractional flow reserve (FFR) and optical coherence tomography (OCT) of the LAD with the OpSens FFR system as part of their routine evaluation asstandard of care procedure.

• Provides written, informed consent and HIPAA consent to use the data in a clinicalstudy.

Exclusion Criteria:

(General exclusion criteria)

• Patients presented with NSTEMI with the LAD involved as the culprit lesion

• Any ST-elevation myocardial infarction within the past 30 days.

• Hemodynamic instability requiring vasopressor or mechanical circulatory support.

• Prior heart transplant.

• Known left ventricular ejection fraction ≤40%.

• LAD supplying akinetic or severely hypokinetic territories if already known based onprior imaging.

• Patient is enrolled in another clinical study that may impact the results of thisstudy.

• FFR not acquired per instructions for the OpSens Wire.

• LAD Lesion not assessed with OCT.

(Angiographic exclusion criteria)

• Thrombolysis in Myocardial Infarction (TIMI) grade 2 or lower at baselineangiography.

• Target lesion involves left main (stenosis >50%).

• Previous percutaneous coronary intervention (PCI) with stent in LAD or left maintrunk.

• Presence of chronic total occlusion in any vessel.

• Presence of a side branch≥2.75 mm with ≥70% stenosis in the LAD.

• Bifurcation lesion that resulted in the stent implantation of a side branch.