Assessment of Coronary Pressure Using the Combined Guidewire and Catheter Wirecath

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.

Study Overview

• Status: Completed
• Conditions: Coronary Disease
• Intervention / Treatment: Device: Wirecath@ and Abbott PressureWire® (20 patients); Device: Wirecath® (20 patients); Device: Coronary flow reserve

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mats Hilmersson; Phone Number: +46 704931307; Email: mats.hilmersson@cavistechnologies.com

Study Locations

• Sweden
  • Gothenburg, Sweden, 41345
    • Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Study arm; 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)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of the Wirecath® will be assessed through the frequency and severity of all adverse events	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.	30-60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison with Abbott pressure wire	comparing the Wirecath measurement values with the measurement values of a regular sensor-tipped pressure guidewire during simultaneous measurements in the same vessel.	30-60 minutes
Comparing pressure-derived coronary flow reserve (CFR) with bolus-thermo CFR, absolute flow CFR and non-invasive doppler derived CFR	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	14 days

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Collaborators: Cavis Technologies AB
• Investigators: Principal Investigator: Oskar Angerås, MD PhD, Sahlgrenska University Hospital, Gothenburg, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2021
• Primary Completion (Actual): October 25, 2021
• Study Completion (Actual): October 25, 2021

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: coronary disease; coronary flow reserve; fractional flow reserve; pressure wire
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Coronary Disease
• Other Study ID Numbers: 0100P

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No