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Evaluation of Accuracy of CFD-based RuiXin-FFR by Comparing With Pressure-wire-based FFR

NCT04731285 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 316

Last updated 2021-09-05

No results posted yet for this study

Summary

Coronary Artery Disease (CAD) is the top killer nowadays. Pressure-wire-based Fractional Flow Reserve (FFR) is the gold standard for measuring ischemia in coronary arteries. CFD-based RuiXin-FFR, which is noninvasive, is developed recently. But its accuracy is not verified. This is a multi-center and prospective study to evaluate the sensitivity, specificity, and accuracy of CFD-based RuiXin-FFR compared with wire-based FFR.

Conditions

Interventions

DIAGNOSTIC_TEST

Pressure wire fractional flow reserve

Pressure wire is inserted into coronary arteries. The ratio of the average distal pressure and average aorta pressure is FFR.

DIAGNOSTIC_TEST

CFD-based RuiXin-FFR

CT-FFR was evaluated in a blinded fashion with a "Coarse-to-Fine Subpixel" algorithm for lumen contour

Sponsors & Collaborators

  • Beijing Anzhen Hospital

    lead OTHER

Principal Investigators

  • Zhanquan Li, MD · Liaoning Provincial People's Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-13
Primary Completion
2020-05-14
Completion
2020-08-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04731285 on ClinicalTrials.gov