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

NCT ID: NCT03848650

Last Updated: 2024-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-19
• Study Completion Date: 2019-05-13

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.

Conditions

Left Anterior Descending Coronary Artery Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Opsens Medical OptoWire

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

Group Type: EXPERIMENTAL

OpSens Medical OptoWire

Intervention Type: DEVICE

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.

FFR

Intervention Type: PROCEDURE

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).

Interventions

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.

Intervention Type: DEVICE

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).

Intervention Type: PROCEDURE

Other Intervention Names

OpSens Medical OptoWire Deux FFR System; Fractional Flow Reserve

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

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manish Parikh, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

New York Presbyterian Hospital/Columbia University Medical Center

New York, New York, United States

St. Francis Hospital

Roslyn, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AAAR7661

Identifier Type: -

Identifier Source: org_study_id