- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02480569
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
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
-
-
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
|
|
EXPERIMENTAL: Non-Side-Hole Catheter
2 FFR measurements from an engaged non-side-hole guide catheter and a disengaged non-side-hole guide catheter
|
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.
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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