Sahlgrenska University Hospital
Gothenburg, 41345, Sweden
NCT Number: NCT04776577
In summary, the purpose of the study is to evaluate whether the Wirecath device can be used as a standard pressure wire in a safe and efficient way.
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Notify Me19 year and older
All sexes
Interventional
Not applicable
Gothenburg, 41345, Sweden
Simultaneous measurements study (group 1) This group will be recruited and assessed in parallel with recruitment to group 2 at the discretion of the treating physician, based on the resource availability in the cath lab.
In the simultaneous measurements study group, measurements will be collected from a Wirecath® and a regular sensor-tipped pressure wire in the same position in the coronary artery at the same time (simultaneously). The regular wire to be used is the market leading Abbott PressureWire®.
By comparing the pressure measurements (Pd) from Wirecath® and from a regular sensor-tipped wire, we intend to examine if the pressure reported by the two wires deviate in any way. If a deviation exists, the hydrostatic error, caused by the height difference between the positions of Pa and Pd when using a sensor-tipped wire, will be assessed.
In FFR-negative patients, after removal of the Wirecath®, the Abbott PressureWire® is used in LAD
Wirecath will be used for PCI when indicated and performance documented by follow-up questions to the users.
Regular study group (group 2) In the regular use study group, the Wirecath® is to be used as a regular pressure measurement tool, replacing the regularly used pressure wire.
Pressure measurement results will be collected.
Wirecath® will be used for PCI when indicated and performance documented by follow-up questions to the users.
In FFR-negative patients, after removal of the Wirecath®, the Abbott PressureWire® is used in LAD
Echocardiography-CFR group (group 3) Patients from group 1 and group 2 that have undergone Bolus-thermo and Absolute-flow CFR measurements, will be recruited to group 3. In this group echocardiography-CFR (Echo CFR) will be measured within 14 days. The echocardiography is performed according to the standard procedure of the hospital. The correlation between the methods will be investigated.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Simultaneous FFR measurements with Wirecath@ and Abbott PressureWire®
FFR measurement with Wirecath® only
Pressure derived CFR with Wirecath®, Thermodilution CFR with Abbott PressureWire®, Absolut flow CFR with Abbott PressureWire® and Hexacath Rayflow catheter®, Non-invasive echo derived CFR
Time frame: 30-60 minutes
The safety of the Wirecath@ will be assessed through the frequency and severity of all adverse events reported for study subjects after the completion of the pressure measurement and PCI. The primary endpoint will be achieved when the device has been used on enrolled patients and required measurements have been taken.
Time frame: 30-60 minutes
comparing the Wirecath measurement values with the measurement values of a regular sensor-tipped pressure guidewire during simultaneous measurements in the same vessel.
Time frame: 14 days
In FFR negative LADs, comparing the Wirecath® pressure-derived CFR values with CFR derived from thermodilution, absolute flow and echocardiography-CFR values. This secondary endpoint will be achieved if these values correlate
Vastra Gotaland Region
Other Gov
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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