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

January 9, 2016 updated by: Emmanouil Brilakis, North Texas Veterans Healthcare System
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75216
        • Dallas VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Side-Hole Catheter
2 FFR measurements from an engaged side-hole guide catheter and a disengaged side-hole guide catheter
Other: FFR Measurement
EXPERIMENTAL: Non-Side-Hole Catheter
2 FFR measurements from an engaged non-side-hole guide catheter and a disengaged non-side-hole guide catheter
Other: FFR Measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
FFR measurement using a guide catheter with and without side holes
Time Frame: Less than 1 hour during the coronary angiography
Less than 1 hour during the coronary angiography

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North Texas Veterans Healthcare System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

November 1, 2015

Study Registration Dates

First Submitted

June 17, 2015

First Submitted That Met QC Criteria

June 22, 2015

First Posted (ESTIMATE)

June 24, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

January 12, 2016

Last Update Submitted That Met QC Criteria

January 9, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-033

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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