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

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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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

FFR Measurement

Other

Primary outcomes

FFR measurement using a guide catheter with and without side holes

Time frame: Less than 1 hour during the coronary angiography

Sponsors and collaborators

Lead sponsor

North Texas Veterans Healthcare System

Fed

Registry information

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Jun 24, 2015
Registry last updated: Jan 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed