NCT04776577

Assessment of Coronary Pressure Using the Combined Guidewire and Catheter Wirecath

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Coronary Disease

Interventions

Type	Name	Description
DEVICE	Wirecath@ and Abbott PressureWire® (20 patients)	Simultaneous FFR measurements with Wirecath@ and Abbott PressureWire®
DEVICE	Wirecath® (20 patients)	FFR measurement with Wirecath® only
DEVICE	Coronary flow reserve	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

Timeline

• Start date: 2021-02-25
• Primary completion: 2021-10-25
• Completion: 2021-10-25
• First posted: 2021-03-01
• Last updated: 2024-01-09

Locations

1 site across 1 country: Sweden