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

NCT03848650 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-06-11

Study results available
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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.

Conditions

  • Left Anterior Descending Coronary Artery Stenosis

Interventions

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.

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).

Sponsors & Collaborators

Principal Investigators

  • Manish Parikh, MD · Columbia University

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-19
Primary Completion
2019-05-13
Completion
2019-05-13
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03848650 on ClinicalTrials.gov