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Physiological Patterns of Coronary Artery Disease

Physiological Patterns of Coronary Artery Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03824600
Enrollment
117
Registered
2019-01-31
Start date
2017-11-24
Completion date
2019-09-30
Last updated
2020-03-30

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

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.

Interventions

DIAGNOSTIC_TESTFractional 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.

Sponsors

Onze Lieve Vrouw Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

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

Other

MeasureTime frameDescription
Classification of the physiological patterns of coronary artery disease using a quantitative metricImmediate post-procedure. No follow-up is schedule for this trial.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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026