Ignite Creation Date:
2024-05-06 @ 10:20 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03227588
Status:
UNKNOWN
Last Update Posted:
2019-02-12
First Post:
2017-06-27
Brief Title:
Evaluation of the Opsens Fractional Flow Reserve FFR Wire as a Work Horse Wire
Sponsor:
Central Arkansas Veterans Healthcare System
Organization:
Central Arkansas Veterans Healthcare System
Study Overview
Official Title:
Evaluation of the Opsens Fractional Flow Reserve FFR Wire as a Work Horse Wire
Status:
UNKNOWN
Status Verified Date:
2019-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 0014 guidewire An FFR of 080 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
Detailed Description:
EVALUATION OF THE OPSENS FRACTIONAL FLOW RESERVE FFR WIRE AS A WORK HORSE WIRE
INVESTIGATORS
PRINCIPAL INVESTIGATOR BARRY F URETSKY MD CO-INVESTIGATOR ABDUL HAKEEM MD CO-INVESTIGATOR MALEK AL-HAWWAS MD
Introduction 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 0014 guidewire The wire is passed distal to the stenosis Under the condition of maximal hyperemia induced by a drug typically adenosine the pressure proximal to the stenosis ie aortic pressure or Pa and the pressure distal to the stenosis Pd are measured The ratio PdPa under maximal flow or hyperemia is known as the fractional flow reserve FFR An FFR of 080 has been correlated with observed myocardial ischemia using other diagnostic methods particularly 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 1 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 23
One of the limitations of the use of the FFR pressure wire itself is that its handling characteristics are somewhat inferior to a standard work horse guide wire used for PCI 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 There are several different work horse wires available Although the wires may be different for different Cath Labs and operators the wires are universally used to maximize safety efficacy and efficiency of PCI
In patients specifically requiring FFR to determine the value of PCI it would be ideal if an FFR wire was as effective as a work horse wire so it could be used in difficult-to-traverse lesions However due to the complex electronics within current FFR wires handling characteristics of previously used wires are inferior to current work horse wires Recently the FDA has approved an FFR guide wire OptoWire Opsens Quebec City Quebec CAN using light transmission to measure pressure rather than electrical transduction 4 It is commercially available in the United States Its handling characteristics appear to approach that of a work horse guide wire and may represent an improvement over 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 occuring 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
In clinical practice FFR is performed before and often after PCI In a study of 574 patients treated at the Little Rock VA IRB Study 779601 teh investigators found that approximately 20 of angiographically optimized PCI still had an ischemic FFR The investigators further found that this ischemic value could be improved by further treatments including balloon angioplasty and stenting Thus the secondary purpose is to measure FFR after successful PCI to ascertain the incidence of persistently ischemic FFR after optimized angiographic stenting to confirm the result from out previous study
Statistical analysis
This study is descriptive It will use means and standard deviation for continuous variables and prevalence or incidence in percentages as appropriate to show results As there is no comparator group comparative statistics will not be employed
Research aspect of study
The research aspect of the study is limited to the systematic collection and analysis of data using the Opsens FFR wire with plan for publication The other aspects of the study are considered part of routine clinical care They include passage of FFR wire measurement of FFR pre- and post-PCI and performance of PCI itself
Significance of study
A wire that can be used as a workhorse as well as be able to measure FFR would be of great value The more effective and efficient is the FFR wire in not only measuring pre-PCI FFR but being able to be used for PCI and be stable and durable enough to be used for post-PCI optimization the greater is the probability that this approach will be more generally adopted into clinical practice Demonstration that the Opsens FFR wire is effective in this regard should further this goal
The investigators previously demonstrated that 21 or about 1 in 5 patients had an ischemic FFR after satisfactory angiographic result This study will confirm previous results or suggest either an over- or under-estimation of that incidence
INVESTIGATORS
PRINCIPAL INVESTIGATOR BARRY F URETSKY MD CO-INVESTIGATOR ABDUL HAKEEM MD CO-INVESTIGATOR MALEK AL-HAWWAS MD
Introduction 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 0014 guidewire The wire is passed distal to the stenosis Under the condition of maximal hyperemia induced by a drug typically adenosine the pressure proximal to the stenosis ie aortic pressure or Pa and the pressure distal to the stenosis Pd are measured The ratio PdPa under maximal flow or hyperemia is known as the fractional flow reserve FFR An FFR of 080 has been correlated with observed myocardial ischemia using other diagnostic methods particularly 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 1 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 23
One of the limitations of the use of the FFR pressure wire itself is that its handling characteristics are somewhat inferior to a standard work horse guide wire used for PCI 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 There are several different work horse wires available Although the wires may be different for different Cath Labs and operators the wires are universally used to maximize safety efficacy and efficiency of PCI
In patients specifically requiring FFR to determine the value of PCI it would be ideal if an FFR wire was as effective as a work horse wire so it could be used in difficult-to-traverse lesions However due to the complex electronics within current FFR wires handling characteristics of previously used wires are inferior to current work horse wires Recently the FDA has approved an FFR guide wire OptoWire Opsens Quebec City Quebec CAN using light transmission to measure pressure rather than electrical transduction 4 It is commercially available in the United States Its handling characteristics appear to approach that of a work horse guide wire and may represent an improvement over 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 occuring 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
In clinical practice FFR is performed before and often after PCI In a study of 574 patients treated at the Little Rock VA IRB Study 779601 teh investigators found that approximately 20 of angiographically optimized PCI still had an ischemic FFR The investigators further found that this ischemic value could be improved by further treatments including balloon angioplasty and stenting Thus the secondary purpose is to measure FFR after successful PCI to ascertain the incidence of persistently ischemic FFR after optimized angiographic stenting to confirm the result from out previous study
Statistical analysis
This study is descriptive It will use means and standard deviation for continuous variables and prevalence or incidence in percentages as appropriate to show results As there is no comparator group comparative statistics will not be employed
Research aspect of study
The research aspect of the study is limited to the systematic collection and analysis of data using the Opsens FFR wire with plan for publication The other aspects of the study are considered part of routine clinical care They include passage of FFR wire measurement of FFR pre- and post-PCI and performance of PCI itself
Significance of study
A wire that can be used as a workhorse as well as be able to measure FFR would be of great value The more effective and efficient is the FFR wire in not only measuring pre-PCI FFR but being able to be used for PCI and be stable and durable enough to be used for post-PCI optimization the greater is the probability that this approach will be more generally adopted into clinical practice Demonstration that the Opsens FFR wire is effective in this regard should further this goal
The investigators previously demonstrated that 21 or about 1 in 5 patients had an ischemic FFR after satisfactory angiographic result This study will confirm previous results or suggest either an over- or under-estimation of that incidence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None