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

Status unconfirmed

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT03227588

Run by

Central Arkansas Veterans Healthcare System

People needed

1000

Starts

2017-04-10

Expected to finish

2019-12-10

Last updated by the study team

2019-02-12

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients (age 18-89 years old) eligible and in whom the operator has performed FFR will be included to systematically evaluate the performance of the OptoWire FFR wire. A total of 1000 consecutive patients deemed to require FFR as part of clinical care will be included. It is felt that 1000 patients represent a reasonable sample size to study the OptoWire FFR wire handling characteristics, the primary endpoint of the study

You may not qualify if…

• Not a candidate for FFR
• Chronic total occlusion lesion
• Hemodynamically unstable
• Saphenous vein graft lesions -

Where it is running

• John L. McClellan Memorial Veterans Hospital — Little Rock, Arkansas, United States (enrolling)

Full record on ClinicalTrials.gov

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