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

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

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.

Study Overview

• Status: Completed
• Conditions: Left Anterior Descending Coronary Artery Stenosis
• Intervention / Treatment: Device: OpSens Medical OptoWire; Procedure: FFR

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • New York Presbyterian Hospital/Columbia University Medical Center
    • Roslyn, New York, United States, 11576
      • St. Francis Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Opsens Medical OptoWire; Subjects who will have or recently had FFR using the Opsens Medical OptoWire Deux FFR system.

Device: OpSens Medical OptoWire; The OptoWire is FDA approved to measure pressure in coronary vessels during diagnostic angiography and coronary interventions. The OptoWire Deux pressure wire (OpSens Medical, Quebec, Canada) is a novel technology utilizing optical coherence technology to enhance FFR assessment of the coronaries.; Other Names: OpSens Medical OptoWire Deux FFR System; Procedure: FFR; A guide wire-based procedure that can accurately measure blood pressure and flow through a specific part of the coronary artery. FFR is done through a standard diagnostic catheter at the time of a coronary angiogram (a.k.a. cardiac catheterization).; Other Names: Fractional Flow Reserve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Recordings of Significant Drift in Pre and Post-PCI	The rate of significant drift is defined as FFR <0.97 or >1.03 with the in the pre-percutaneous coronary intervention (PCI) FFR recording using the OpSens OptoWire Deux pressure wire system. FFR is calculated by measuring the ratio between pressure distal to a stenosis and pressure proximally to stenosis using specialized pressure-measuring guidewires during maximal hyperemia.	During procedure, approximately less than an hour

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Manish Parikh, MD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2018
• Primary Completion (Actual): May 13, 2019
• Study Completion (Actual): May 13, 2019

Study Registration Dates

• First Submitted: February 19, 2019
• First Submitted That Met QC Criteria: February 19, 2019
• First Posted (Actual): February 21, 2019

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 10, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: FFR OCT LAD
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Coronary Stenosis
• Other Study ID Numbers: AAAR7661

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan to share individual participant data (IPD) with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No