Trial to Compare FFR Measurement With a Non-Side-Hole Guide Catheter Vs. a Side-Hole Guide Catheter

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Other: FFR Measurement

• Registration Number: NCT02480569
• Lead Sponsor: North Texas Veterans Healthcare System

Brief Summary

The investigators propose a single center prospective study that will assess two different strategies for measuring Fractional Flow Reserve (FFR) in patients undergoing clinically-indicated coronary angiography in whom FFR measurement is indicated. FFR will be measured with a non-side hole guide catheter (with the guide catheter both engaged and disengaged from the coronary ostium) and with a side-hole guide catheter (with the guide catheter both engaged and disengaged from the coronary ostium) to determine, whether measurements obtained with an engaged side-hole guide catheter are more accurate as compared with those obtained with the engaged non-side hole catheter.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-17
• Study First Submitted QC: 2015-06-22
• Study First Posted: 2015-06-24
• Primary Completion: 2015-07
• Study Completion: 2015-11
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-09
• Last Update Posted: 2016-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Undergoing a clinically indicated coronary catheterization
• Need FFR of a coronary artery lesion
• Agree to participate and able to provide informed consent

Exclusion Criteria

• Significant difficulty advancing the pressure measuring guidewire into the coronary artery
• Severe chronic obstructive pulmonary disease
• Severe ostial disease (>70% diameter stenosis within 5 mm from the coronary artery ostium)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Side-Hole Catheter	FFR Measurement	2 FFR measurements from an engaged side-hole guide catheter and a disengaged side-hole guide catheter
Non-Side-Hole Catheter	FFR Measurement	2 FFR measurements from an engaged non-side-hole guide catheter and a disengaged non-side-hole guide catheter

Primary Outcome Measures

Name	Time	Method
FFR measurement using a guide catheter with and without side holes	Less than 1 hour during the coronary angiography

Trial Locations

Locations (1)

Dallas VA Medical Center; 🇺🇸 Dallas, Texas, United States