Pressure Guidewire Comparative In Patients Study

Recruiting

• Conditions: Coronary artery disease; Intravascular blood pressure; 10011082

• Registration Number: NL-OMON45355
• Lead Sponsor: Jeroen Bosch Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Patients with at least one lesion indicated for FFR

Exclusion Criteria

More than 3 lesions indicated for FFR measurements
Type C lesions
Lesions with angiographic 'haziness' or suspected to contain thrombus

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The FFR measurement reliability is assessed by two measures. First reliability<br /><br>is assessed by tracking and recording the drift caused by the pressure<br /><br>guidewire residing within the coronary artery. This is determined by the value<br /><br>of Pd/Pa before and after the procedure when pulled back just outside the<br /><br>guiding catheter.<br /><br><br /><br>Secondly, FFR reliability is assessed by the stability of Pd/Pa during constant<br /><br>hyperemia.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The wire handling performance is assessed by scoring both wires by the same<br /><br>investigator in the same patient. The following characteristics are scored on a<br /><br>5 point scale: torquability, steerability, pushability and support. The wire<br /><br>performance is also assessed by measuring the time it takes to reach and cross<br /><br>the lesion.</p><br>