Physiological Patterns of Coronary Artery Disease

Coronary Artery Disease Clinical Trial

Official title:

Physiological Patterns of Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03824600
• Other study ID #: CRI-0002
• Status: Completed
• Start date: November 24, 2017
• Est. completion date: September 30, 2019

Study information

• Verified date: March 2020
• Source: Onze Lieve Vrouw Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: September 30, 2019
• Est. primary completion date: August 30, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Diagnostic Test:
• Fractional Flow Reserve Motorized Pullback
A pullback device (Volcano R 100, San Diego CA, USA), adapted to grip the coronary pressure wire (PressureWire X, St Jude Medical, Minneapolis, USA), set at a speed of 1 mm/sec to pullback the pressure-wire until the tip of the guiding catheter during continued pressure recording.

Locations

Country	Name	City	State
Belgium	OLV Aalst	Aalst	West Flanders
Belgium	University of Brussels	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Onze Lieve Vrouw Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Classification of the physiological patterns of coronary artery disease using a quantitative metric	Based on the data obtained using the fractional flow reserve pullbacks and conventional coronary angiography a quantitative classification of the physiological pattern of coronary artery disease based on the functional contribution of the epicardial lesion (i.e. lesion-related pressure drop) with respect to the total vessel fractional flow reserve will be explored.	Immediate post-procedure. No follow-up is schedule for this trial.
Primary	Physiological Patterns of Coronary Artery Disease (i.e. focal, diffuse or combined)	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).	Immediate post-procedure. No follow-up is schedule for this trial.