CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
OpSens Medical OptoWire +1 moredevice
Likely dose
Not stated in record
Key inclusion· 5
  • Age >18 years, male or female
  • Stable angina, unstable angina, or NSTEMI (if LAD is non-culprit lesion)
  • Intermediate proximal LAD de novo stenosis 30–80% with TIMI flow 3 on angiography
  • FFR and OCT of the LAD already performed with OpSens FFR system as standard of care
Key exclusion· 12
  • NSTEMI with LAD as culprit lesion
  • Any ST-elevation myocardial infarction within past 30 days
  • Hemodynamic instability requiring vasopressor or mechanical circulatory support
  • Prior heart transplant

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03848650
NCT03848650N/ACompleted

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

Columbia University·interventional·Posted Feb 21, 2019·Updated Jun 11, 2024

In Brief

A clinical study evaluating OpSens Medical OptoWire and FFR for Left Anterior Descending Coronary Artery Stenosis. Completed, enrolled 60 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedFeb 21, 2019
Enrollment StartJun 19, 2018
Primary CompletionMay 13, 2019
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 7.4 years ago

Interventions

OpSens Medical OptoWiredevice

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.

FFRprocedure

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).