NCT02480569

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

January 12, 2016

Status Verified

January 1, 2016

Enrollment Period

1 month

First QC Date

June 17, 2015

Last Update Submit

January 9, 2016

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • FFR measurement using a guide catheter with and without side holes

    Less than 1 hour during the coronary angiography

Study Arms (2)

Side-Hole Catheter

EXPERIMENTAL

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

Other: FFR Measurement

Non-Side-Hole Catheter

EXPERIMENTAL

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

Other: FFR Measurement

Interventions

FFR MeasurementOTHER
Non-Side-Hole CatheterSide-Hole Catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing a clinically indicated coronary catheterization
  • Need FFR of a coronary artery lesion
  • Agree to participate and able to provide informed consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emmanouil S Brilakis, MD, PhD

Study Record Dates

First Submitted

June 17, 2015

First Posted

June 24, 2015

Study Start

June 1, 2015

Primary Completion

July 1, 2015

Study Completion

November 1, 2015

Last Updated

January 12, 2016

Record last verified: 2016-01

Locations

US(1)