Assessment of Coronary Pressure Using the Combined Guidewire and Catheter Wirecath
- Conditions
- Coronary Disease
- Interventions
- Device: Wirecath@ and Abbott PressureWire® (20 patients)Device: Wirecath® (20 patients)Device: Coronary flow reserve
- Registration Number
- NCT04776577
- Lead Sponsor
- Vastra Gotaland Region
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- Adults (>18yrs age)
- Informed consent given
- Patients with result from diagnostic angiography
- Indication for coronary pressure assessment
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Study arm Wirecath® (20 patients) 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) Study arm Wirecath@ and Abbott PressureWire® (20 patients) 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) Study arm Coronary flow reserve 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)
- Primary Outcome Measures
Name Time Method Safety of the Wirecath® will be assessed through the frequency and severity of all adverse events 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.
- Secondary Outcome Measures
Name Time Method Comparing pressure-derived coronary flow reserve (CFR) with bolus-thermo CFR, absolute flow CFR and non-invasive doppler derived CFR 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
Comparison with Abbott pressure wire 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.
Trial Locations
- Locations (1)
Sahlgrenska University Hospital
🇸🇪Gothenburg, Sweden