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

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ClinicalTrials.gov Identifier: NCT03227588
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Uretsky, Central Arkansas Veterans Healthcare System

Brief 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.

Condition or disease Intervention/treatment
Coronary Artery Disease Diagnostic Test: Fractional Flow Reserve

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Evaluation of the Opsens Fractional Flow Reserve (FFR) Wire as a "Work Horse" Wire
Actual Study Start Date : April 10, 2017
Estimated Primary Completion Date : December 10, 2019
Estimated Study Completion Date : December 10, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Fractional Flow Reserve
    This is a prospective data collection study for patients that have undergone FFR.


Primary Outcome Measures :
  1. Opsens FFR Wire Performance [ Time Frame: Acute result at end of procedure ]
    Satisfactory performance is defined as the ability to perform the entire PCI plus measure FFR pre and post PCI with drift <0.05.


Secondary Outcome Measures :
  1. Incidence of Ischemic or Low Non-ischemic FFR post PCI requiring further intervention [ Time Frame: Acute result at end of procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Not a candidate for FFR
  2. Chronic total occlusion lesion
  3. Hemodynamically unstable
  4. Saphenous vein graft lesions -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03227588


Contacts
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Contact: Barry F. Uretsky, MD 501-257-1000 barry.uretsky@va.gov
Contact: Kristin G Miller, RN, CCRC 501-257-5893 kristin.miller4@va.gov

Locations
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United States, Arkansas
John L. McClellan Memorial Veterans Hospital Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Kristin Miller, RN    501-257-5893    kristin.miller4@va.gov   
Principal Investigator: Barry F Uretsky, MD         
Sponsors and Collaborators
Central Arkansas Veterans Healthcare System
Investigators
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Principal Investigator: Barry F. Uretsky, MD CAVHS

Additional Information:
Publications:

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Responsible Party: Uretsky, Director of Interventional Cardiology and Cath Lab, Central Arkansas Veterans Healthcare System
ClinicalTrials.gov Identifier: NCT03227588     History of Changes
Other Study ID Numbers: 966635
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Uretsky, Central Arkansas Veterans Healthcare System:
Fractional Flow Reserve
Percutaneous Coronary Intervention

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases