Clinical trial NCT03848650: The Drift-Reduction for Improved FFR Using Fiberoptic Technology (DRIFT) Study
Official title: The Drift-Reduction for Improved Fractional Flow Reserve (FFR) Using Fiberoptic Technology (DRIFT) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Left Anterior Descending Coronary Artery Stenosis
Keywords: FFR OCT LAD
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The primary objective of this study is to assess the accuracy, efficacy, and durability of the OpSens Medical OptoWire Deux pressure wire in the assessment of angiographically intermediate proximal left anterior descending coronary artery (LAD) stenoses in clinical practice.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Recordings of Significant Drift in Pre and Post-PCI
timeFrame: During procedure, approximately less than an hour
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital/Columbia University Medical Center
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
Study officials:
affiliation: Columbia University
name: Manish Parikh, MD
role: PRINCIPAL_INVESTIGATOR
References: