Piezo-electric versus optical versus open wire pressure guidewires for FFR measurements: comparison of two commercially available pressure wires

Phase 4

Completed

• Conditions: Coronary atherosclerosis; fractional flow reserve; percutaneous coronary intervention; 10011082

• Registration Number: NL-OMON51006
• Lead Sponsor: Catharina-ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Patients between the ages of 18 and 80 years scheduled to undergo invasive
measurement of FFR for diagnostic or interventional purposes

Exclusion Criteria

Severe aortic valve stenosis, known conduction disturbances (second- or
third-degree AV block), acute myocardial infarction (CK >1,000 U/L less than 5
days ago), bradycardia (less than 45 beats/min), severe hypotension, extremely
tortuous or calcified coronary arteries precluding FFR measurement, history of
severe asthma, pregnancy and/or inability to provide informed consent.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>- To compare the pressure signals measured by the different available pressure<br /><br>guidewires, specifically the FFR value<br /><br>- To assess the occurrence of hydrostatic errors when using sensor-tipped wires<br /><br>- To assess the occurrence of drift between the different pressure guidewires</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To assess signal quality and stability between the different pressure<br /><br>guidewires<br /><br>- To assess maneuverability and handling of the different pressure guidewires</p><br>