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

This study is designed as a prospective, observational in nature, multi-center, single-arm,
clinical registry to estimate the ischemic burden of angiographically intermediate proximal
LAD stenosis in clinical practice using the OpSens Medical OptoWire Deux FFR system. Subjects
with stable angina or unstable angina who are found to have an intermediate proximal LAD
stenosis on coronary angiography with anatomy amenable to PCI and underwent physiological
lesion assessment with the OptoWire Deux pressure wire and OCT as part of their routine
procedures using standard of care techniques will be enrolled. Patients meeting enrollment
criteria will be offered the opportunity to enroll in this observational registry
post-procedure. All patients enrolled in this study are expected to be evaluated and treated
using a standard of care technique. This study will enroll a total of 60 patients at Columbia
University Medical Center and St. Francis Hospital.

Inclusion Criteria:

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

- Patients with stable angina, unstable angina or non-ST segment elevation myocardial
infarction (if the LAD lesion is the non-culprit lesion) and in whom an intermediate
proximal LAD de novo stenosis (30-80%) with TIMI flow 3 has been identified on
angiography. 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 as standard
of care procedure.

- Provides written, informed consent and HIPAA consent to use the data in a clinical
study.

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 on
prior imaging.

- Patient is enrolled in another clinical study that may impact the results of this
study.

- 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 baseline angiography.

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

- Previous percutaneous coronary intervention (PCI) with stent in LAD or left main
trunk.

- 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.