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Evaluation of the Opsens Fractional Flow Reserve (FFR) Wire as a "Work Horse" Wire

NCT03227588 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2019-02-12

No results posted yet for this study

Summary

The use of fractional flow reserve (FFR) has improved outcomes in percutaneous coronary interventions (PCI) in patients with symptomatic stable coronary artery disease (CAD) with intermediate angiographic stenoses. It is a clinical tool used routinely in cardiac catheterization laboratories throughout the world including the Little Rock VA Hospital. The technique utilizes a pressure transducer constructed as part of an 0.014" guidewire. An FFR of \>0.80 has been linked with myocardial ischemia found with nuclear stress and dobutamine echo stress testing. The FAME trial clearly demonstrated its value in improving long-term outcomes as compared to use of angiography alone. As such, the use of FFR is incorporated into both AHA ACC and European PCI guideline recommendations as part of routine care for intermediate lesions. A "work horse" guide wire is so defined because it can be used in most PCI cases. It combines a low tip load (to avoid intimal dissection, with excellent (ideally, one to one) torque transmission and trackability through tortuous lesions. Recently the FDA has approved an FFR guide wire, OptoWire, (Opsens, Quebec City, Quebec, CAN) which uses light transmission to measure pressure rather than electrical transduction wires. The primary purpose of the present study is to determine how effective this wire is as a work horse wire in patients in whom FFR is required. The OptoWire may also have the advantage of less "drift" occurring during the procedure. Drift refers to the change in pressure due to issues related to the wire and measuring system, rather than a true change in pressure. All current FFR wire systems demonstrate some degree of drift requiring measuring pressure of the wire in the aorta after the procedure is completed to determine if, and to what extent, drift has occurred. Thus, a secondary aim of this study will determine the degree of drift.

Conditions

Interventions

DIAGNOSTIC_TEST

Fractional Flow Reserve

This is a prospective data collection study for patients that have undergone FFR.

Sponsors & Collaborators

  • Central Arkansas Veterans Healthcare System

    lead FED

Principal Investigators

  • Barry F. Uretsky, MD · CAVHS

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-10
Primary Completion
2019-12-10
Completion
2019-12-10

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03227588 on ClinicalTrials.gov