Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04802681
Status:
COMPLETED
Last Update Posted:
2023-07-17
First Post:
2021-03-15
Brief Title:
Pressure Guidewire Comparison
Sponsor:
Lokien van Nunen
Organization:
Catharina Ziekenhuis Eindhoven
Study Overview
Official Title:
Piezo-electric Versus Open Wire Pressure Guidewires for FFR Measurements Comparison of Two Commercially Available Pressure Wires
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
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:
Fractional flow reserve FFR is the current gold standard for correct decision making with respect to revascularization in the catheterization laboratory FFR is measured by using a pressure guidewire equipped with a pressure sensor positioned distal to the stenosis under investigation A newly developed pressure wire using open wire technology has recently become commercially available The purpose of this study is to evaluate whether the Wirecath pressure guidewire can be used as standard pressure guidewire
The effectiveness of the device will be investigated by comparing Wirecath FFR measurements with the measurements of another regular sensor-tipped pressure guidewires during simultaneous FFR measurements in the same vessel
The effectiveness of the device will be investigated by comparing Wirecath FFR measurements with the measurements of another regular sensor-tipped pressure guidewires during simultaneous FFR measurements in the same vessel
Detailed Description:
FFR is a lesion-specific pressure-derived index of functional severity defined as the maximum myocardial blood flow in the presence of an epicardial stenosis compared with the maximum flow in the hypothetical absence of the stenosis FFR is measured by advancing a pressure guidewire into the coronary artery distal to the lesion under investigation and maintained in that position Distal coronary pressure Pd and aortic pressure Pa are measured simultaneously while inducing steady state maximum hyperemia FFR is defined as the lowest value of PdPa achieved during maximum hyperemia An FFR value or 080 indicates the presence of myocardial ischemia and indicates PCI is warranted
Existing 0014 wires with pressure measurement capabilities have been available for more than 20 years Improvements have been done over time but they are still regarded as inferior to ordinary guidewires when it comes to maneuverability and general guidewire properties This is attributed to the microelectronics that are needed to facilitate the pressure measurements in these wires These existing wires also have issues with signal stability which is often referred to as drift Drift is an electronical phenomenon that leads to a slow progressive change in the pressure value over time a not entirely reliable signal quality
A relatively new pressure guidewire Wirecath is an equivalent device to the currently commercially available pressure guidewires In comparative bench tests it has shown very good maneuverability Moreover due to the open wire technology and thus lack of microelectronics throughout the wire the Wirecath has very stable signal properties and is according to physical law and bench testing immune against a hydrostatic error and less affected by drifting of the signal which are limitations with current pressure guidewires
This study is designed to examine and compare the pressure measurements of two commercially available pressure guidewires Abbott and Cavis Technologies by simultaneously measuring FFR in the same coronary artery with two different pressure guidewires
Existing 0014 wires with pressure measurement capabilities have been available for more than 20 years Improvements have been done over time but they are still regarded as inferior to ordinary guidewires when it comes to maneuverability and general guidewire properties This is attributed to the microelectronics that are needed to facilitate the pressure measurements in these wires These existing wires also have issues with signal stability which is often referred to as drift Drift is an electronical phenomenon that leads to a slow progressive change in the pressure value over time a not entirely reliable signal quality
A relatively new pressure guidewire Wirecath is an equivalent device to the currently commercially available pressure guidewires In comparative bench tests it has shown very good maneuverability Moreover due to the open wire technology and thus lack of microelectronics throughout the wire the Wirecath has very stable signal properties and is according to physical law and bench testing immune against a hydrostatic error and less affected by drifting of the signal which are limitations with current pressure guidewires
This study is designed to examine and compare the pressure measurements of two commercially available pressure guidewires Abbott and Cavis Technologies by simultaneously measuring FFR in the same coronary artery with two different pressure guidewires
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?:
False
Is an FDA AA801 Violation?:
None