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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Side-Hole Catheter

2 FFR measurements from an engaged side-hole guide catheter and a disengaged side-hole guide catheter

Group Type EXPERIMENTAL

FFR Measurement

Intervention Type OTHER

Non-Side-Hole Catheter

2 FFR measurements from an engaged non-side-hole guide catheter and a disengaged non-side-hole guide catheter

Group Type EXPERIMENTAL

FFR Measurement

Intervention Type OTHER

Interventions

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FFR Measurement

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No