MedTrace Logo

The Sensitivity and Specificity of CardioSimFFRct Analysis Software on Coronary Artery Stenosis

NCT04569669 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 325

Last updated 2020-09-30

No results posted yet for this study

Summary

The device involved in this trail is a diagnostic software with a Prospective, Multicenter, Self Controlled design. FFRCT diagnostic performance was calculated by CardioSimFFRct Analysis software, and the diagnostic accuracy, sensitivity, specificity, positive predictive value and negative predictive performance of FFRCT for myocardial ischemia were calculated per-patient level and per-vessel level with invasive FFR value as gold standard.

Conditions

  • Coronary Stenosis

Interventions

DIAGNOSTIC_TEST

FFR and FFRCT

All the patients will undergo computed coronary tomography angiography to analysis FFRCT . Then FFR will be measured during invasive cardiac catheterization.

Sponsors & Collaborators

  • Shengshi Technology, Co., Ltd, Hangzhou, China

    collaborator UNKNOWN

  • CCRF Inc., Beijing, China

    lead INDUSTRY

Principal Investigators

  • Yaling Han, professor · The General Hospital of Northern Theater Command

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-09
Primary Completion
2021-10-09
Completion
2022-03-09

Countries

  • China

Study Locations

More Related Trials

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 NCT04569669 on ClinicalTrials.gov