Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03848650
Study type Interventional
Source Columbia University
Contact Kate Dalton, MS
Phone 347-514-3366
Email keb2114@cumc.columbia.edu
Status Recruiting
Phase N/A
Start date June 19, 2018
Completion date January 2021

See also
  Status Clinical Trial Phase
Recruiting NCT05143671 - Prospective Evaluation for Hybrid Cardiac Procedures
Recruiting NCT05726604 - 4D CT Scan Versus 3D CT Scan Concerning Cardiac Dosimetry Assesment for Left Sided Breast Cancers Radiotherapy N/A