Assessment of Coronary Pressure Using the Combined Guidewire and Catheter Wirecath

Vastra Gotaland Region

Status: Completed

Conditions: Coronary Disease

Treatments: Device: Wirecath@ and Abbott PressureWire® (20 patients); Device: Coronary flow reserve; Device: Wirecath® (20 patients)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04776577

0100P

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults (>18yrs age)
• Informed consent given
• Patients with result from diagnostic angiography
• Indication for coronary pressure assessment

Exclusion criteria

• Patients with known Heparin-Induced Thrombocytopenia (HIT) or allergy to heparin.
• Inability to tolerate Adenosine
• Any condition, e.g. unstable health, which in the opinion of the investigator makes the patient unsuitable for inclusion (Decision documented in inclusion log).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Study arm

Other group

Description:

Group 1 and group 2 will be recruited and assessed in parallel at the discretion of the treating physician, based on the characteristics of the patient. Group 3 will be recruited from suitable patients in group 1 and 2. Simultaneous measurements study (group 1) Regular study group (group 2) Echocardiography-CFR group (group 3)

Treatment:

Device: Wirecath@ and Abbott PressureWire® (20 patients)

Device: Wirecath® (20 patients)

Device: Coronary flow reserve