NCT03848650

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2018-06-19
• Primary completion: 2019-05-13
• Completion: 2019-05-13
• First posted: 2019-02-21
• Last updated: 2024-06-11
• Results posted: 2024-06-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study