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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02480569
Enrollment
25
Registered
2015-06-24
Start date
2015-06-30
Completion date
2015-11-30
Last updated
2016-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

Sponsors

North Texas Veterans Healthcare System
Lead SponsorFED

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
FFR measurement using a guide catheter with and without side holesLess than 1 hour during the coronary angiography

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026