Assessment of Coronary Pressure Using the Combined Guidewire and Catheter Wirecath

NCT04776577 | Completed

• 1 other identifier: 0100P
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Disease

Keywords

coronary disease; fractional flow reserve; coronary flow reserve; pressure wire

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Comparison with Abbott pressure wire

  30-60 minutes

• Comparing pressure-derived coronary flow reserve (CFR) with bolus-thermo CFR, absolute flow CFR and non-invasive doppler derived CFR

  14 days

Study Arms (1)

Study arm

OTHER

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); Device: Wirecath® (20 patients); Device: Coronary flow reserve

Interventions

Wirecath@ and Abbott PressureWire® (20 patients) DEVICE

Simultaneous FFR measurements with Wirecath@ and Abbott PressureWire®

Study arm

Wirecath® (20 patients) DEVICE

FFR measurement with Wirecath® only

Study arm

Coronary flow reserve DEVICE

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

Study arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with known Heparin-Induced Thrombocytopenia (HIT) or allergy to heparin.
• Inability to tolerate Adenosine

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Cavis Technologies AB: collaborator

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Related Publications (1)

• Ramunddal T, Dworeck C, Torild P, Andreen S, Gan LM, Hirlekar G, Ioanes D, Myredal A, Odenstedt J, Petursson P, Pylova T, Topel F, Volz S, Hilmersson M, Redfors B, Angeras O. Safety and Feasibility Using a Fluid-Filled Wire to Avoid Hydrostatic Errors in Physiological Intracoronary Measurements. Cardiol Res Pract. 2024 Jan 2;2024:6664482. doi: 10.1155/2024/6664482. eCollection 2024.

  PMID: 38204600 DERIVED

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Oskar Angerås, MD PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Results from simultaneous measurements with two wires will be graphically showed using the Bland-Altman plot and reported in terms of intraclass correlation coefficient (ICC). Also, whether a theoretical correction for the expected hydrostatic pressure error (0.77 mmHg per cm height difference) at the distal pressure measurement site (Pd) accounts for the difference in FFR during simultaneous measurements will be explored, and a corrected ICC reported. A two-sided p-value of \<0.05 will be considered to be significant, when applicable. The Pearson's correlation coefficient will be also calculated considering the Wirecath FFR value in comparison to the FFR value made with the regular wire with and without correction for hydrostatic error. For the CFR values, the Pearson's correlation coefficient will be used to determine the relation between the bolus-thermo CFR, absolute-flow CFR, Echo CFR and the pressure-derived CFR in the LAD.

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 1, 2021
• Study Start: February 25, 2021
• Primary Completion: October 25, 2021
• Study Completion: October 25, 2021
• Last Updated: January 9, 2024

Record last verified: 2021-02

Locations

SE (1)