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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FFR Measurement
Sponsored by
North Texas Veterans Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Dallas VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Side-Hole Catheter

Non-Side-Hole Catheter

Arm Description

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

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

Outcomes

Primary Outcome Measures

FFR measurement using a guide catheter with and without side holes

Secondary Outcome Measures

Full Information

First Posted
June 17, 2015
Last Updated
January 9, 2016
Sponsor
North Texas Veterans Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT02480569
Brief Title
Trial to Compare FFR Measurement With a Non-Side-Hole Guide Catheter Vs. a Side-Hole Guide Catheter
Official Title
Trial to Compare FFR Measurement With a Non-Side-Hole Guide Catheter Vs. a Side-Hole Guide Catheter
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
North Texas Veterans Healthcare System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Side-Hole Catheter
Arm Type
Experimental
Arm Description
2 FFR measurements from an engaged side-hole guide catheter and a disengaged side-hole guide catheter
Arm Title
Non-Side-Hole Catheter
Arm Type
Experimental
Arm Description
2 FFR measurements from an engaged non-side-hole guide catheter and a disengaged non-side-hole guide catheter
Intervention Type
Other
Intervention Name(s)
FFR Measurement
Primary Outcome Measure Information:
Title
FFR measurement using a guide catheter with and without side holes
Time Frame
Less than 1 hour during the coronary angiography

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Dallas VA Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States

12. IPD Sharing Statement

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

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