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Clinical Trials/NCT03824600
NCT03824600
Completed
Not Applicable

Physiological Patterns of Coronary Artery Disease

Onze Lieve Vrouw Hospital2 sites in 1 country117 target enrollmentNovember 24, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Onze Lieve Vrouw Hospital
Enrollment
117
Locations
2
Primary Endpoint
Physiological Patterns of Coronary Artery Disease (i.e. focal, diffuse or combined)
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Registry of patients undergoing invasive fractional flow reserve measurement using a motorized device.

Detailed Description

A prospective registry of patients undergoing clinically indicated coronary angiography with fractional flow reserve evaluation for vessels with intermediate coronary lesions defined as visual diameter stenosis between 30% and 70%. A motorized fractional flow reservepullback evaluation will be performed at the discretion of the operators. The objective of the present study is to describe the physiological patterns of coronary artery disease using motorized coronary pressure pullbacks during continuous hyperemia in patients with stable coronary artery disease.

Registry
clinicaltrials.gov
Start Date
November 24, 2017
End Date
September 30, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Onze Lieve Vrouw Hospital
Responsible Party
Principal Investigator
Principal Investigator

Jeroen Sonck

Co-Director Catheterization Laboratory

Onze Lieve Vrouw Hospital

Eligibility Criteria

Inclusion Criteria

  • Stable coronary artery disease

Exclusion Criteria

  • acute coronary syndromes
  • previous coronary artery bypass grafting
  • significant valvular disease
  • severe obstructive pulmonary disease or asthma bronchial
  • severe tortuosity or severe calcification

Outcomes

Primary Outcomes

Physiological Patterns of Coronary Artery Disease (i.e. focal, diffuse or combined)

Time Frame: Immediate post-procedure. No follow-up is schedule for this trial.

Describe the physiological patterns of coronary artery disease using motorized coronary pressure pullbacks during continuous hyperemia in patients with stable coronary artery disease. A pullback device adapted to grip the coronary pressure wire with a speed of 1 mm/sec during continued pressure recording will be used. A fractional flow reserve value every 100 microns will be extracted from the pressure tracing and plotted against the length to generate a pullback curve. Fractional flow reserve will be defined as the ratio of the moving average of the proximal and distal coronary pressures. The patterns of physiological disease will be classified as focal or diffuse according to the visual inspection of the fractional flow reserve pullback curve. The patterns of coronary artery disease will be reported as a focal, diffuse or combined pattern (i.e. focal and diffuse).

Study Sites (2)

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