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

V

Veterans Affairs (VA) North Texas Health Care System

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Other: FFR Measurement

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No 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)

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

25 participants in 2 patient groups

Side-Hole Catheter
Experimental group
Description:
2 FFR measurements from an engaged side-hole guide catheter and a disengaged side-hole guide catheter
Treatment:
Other: FFR Measurement
Non-Side-Hole Catheter
Experimental group
Description:
2 FFR measurements from an engaged non-side-hole guide catheter and a disengaged non-side-hole guide catheter
Treatment:
Other: FFR Measurement

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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