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

NCT03848650 | Completed Results FDA Device

• 1 other identifier: AAAR7661
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Left Anterior Descending Coronary Artery Stenosis

Keywords

FFR OCT LAD

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Opsens Medical OptoWire

EXPERIMENTAL

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

Device: OpSens Medical OptoWire; Procedure: FFR

Interventions

OpSens Medical OptoWire 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.

Also known as: OpSens Medical OptoWire Deux FFR System

Opsens Medical OptoWire

FFR 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).

Also known as: Fractional Flow Reserve

Opsens Medical OptoWire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (2)

New York Presbyterian Hospital/Columbia University Medical Center

New York, New York, 10032, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

MeSH Terms

Interventions

Fractional Flow Reserve, Myocardial

Intervention Hierarchy (Ancestors)

Coronary Circulation; Blood Circulation; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Results Point of Contact

• Title: Manish Parikh, MD
• Organization: Columbia University

map2224@cumc.columbia.edu

212-326-8532

Study Officials

• Manish Parikh, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 21, 2019
• Study Start: June 19, 2018
• Primary Completion: May 13, 2019
• Study Completion: May 13, 2019
• Last Updated: June 11, 2024
• Results First Posted: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)