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NCT02480569 Clinical Trial

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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02480569
Other study ID # 15-033
Secondary ID
Status Completed
Phase N/A
First received June 17, 2015
Last updated January 9, 2016
Start date June 2015
Est. completion date November 2015

Study information
Verified date January 2016
Source North Texas Veterans Healthcare System
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Federal Government
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date November 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Other:
• FFR Measurement

Locations
Country Name City State
United States Dallas VA Medical Center Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
North Texas Veterans Healthcare System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary FFR measurement using a guide catheter with and without side holes Less than 1 hour during the coronary angiography No
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