Assessment of Coronary Pressure Using the Combined Guidewire and Catheter Wirecath

Coronary Disease Clinical Trial

Official title: Assessment of Coronary Pressure Using the Combined Guidewire and Catheter Wirecath

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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

• first to measure CFR by saline bolus injections and thermodilution during rest and hyperemia (Bolus-thermo CFR) and

• second together with a Hexacath/Rayflow@ infusion catheter and a saline infusion pump to measure absolute flow during rest and hyperemia that will be used to calculate CFR (Absolute-flow CFR).

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

• first to measure CFR by saline bolus injections and thermodilution during rest and hyperemia (Bolus-thermo CFR) and

• second together with a Hexacath/Rayflow® infusion catheter and a saline infusion pump to measure absolute flow during rest and hyperemia that will be used to calculate CFR (Absolute-flow CFR).

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. ;

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

• NCT number: NCT04776577
• Study type: Interventional
• Source: Vastra Gotaland Region
• Status: Completed
• Phase: N/A
• Start date: February 25, 2021
• Completion date: October 25, 2021