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

Not Applicable

Completed

• Conditions: Left Anterior Descending Coronary Artery Stenosis
• Interventions: Device: OpSens Medical OptoWire; Procedure: FFR

• Registration Number: NCT03848650
• Lead Sponsor: Columbia University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-06-19
• Study First Submitted: 2019-02-19
• Study First Submitted QC: 2019-02-19
• Study First Posted: 2019-02-21
• Primary Completion: 2019-05-13
• Study Completion: 2019-05-13
• Results First Submitted: 2020-08-07
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-10
• Last Update Submitted: 2024-06-10
• Results First Posted: 2024-06-11
• Last Update Posted: 2024-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of Recordings of Significant Drift in Pre and Post-PCI	During procedure, approximately less than an hour	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.

Trial Locations

Locations (2)

New York Presbyterian Hospital/Columbia University Medical Center; 🇺🇸 New York, New York, United States

St. Francis Hospital; 🇺🇸 Roslyn, New York, United States