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

Left Anterior Descending Coronary Artery Stenosis Clinical Trial

— OPSENS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03848650
• Other study ID #: AAAR7661
• Status: Recruiting
• Phase: N/A
• Start date: June 19, 2018
• Est. completion date: January 2021

Study information

• Verified date: February 2019
• Source: Columbia University
• Contact: Kate Dalton, MS
• Phone: 347-514-3366
• Email: keb2114[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2021
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Stenosis
• Left Anterior Descending Coronary Artery Stenosis

Intervention

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).

Locations

Country	Name	City	State
United States	New York Presbyterian Hospital/Columbia University Medical Center	New York	New York
United States	St. Francis Hospital	Roslyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of significant drift	This is to measure efficacy as defined as FFR <0.97 or >1.03 with the pre-PCI FFR recording using the OpSens OptoWire Deux pressure wire system	During procedure, approximately less than an hour