MedTrace Logo

Validation of a Computed Tomography (CT) Based Fractional Flow Reserve (FFR) Software Using the 320 Detector Aquilion ONE CT Scanner.

NCT03149042 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2020-11-17

Study results available
· View outcomes & findings →

Summary

Coronary Computed Tomography Angiography (CCTA) contrast opacification gradients and FFR-CT estimation can aid in the severity estimation of significant atherosclerotic lesions. Currently, FFR-CT algorithms can only be optimized using theoretical models and can only be validated in large multi-center clinical trials. Using patient specific 3D printed coronary phantoms would allow optimization of FFR-CT algorithms with a measured validation technique without the need for large clinical trials. Thus the investigators believe that this study will result in a FFR-CT algorithm/method with a better predictability for arterial lesion severity than those existing on the market today. Flow measurements will be compared with: CT-FFR for both patients and phantoms, angio lab FFR measurements and 30 days follow-up. This pilot clinical study includes \~50 patients over a year and half at GVI.

Conditions

  • Atherosclerosis, Coronary

Interventions

DIAGNOSTIC_TEST

CCTA

Diagnostic Test

Sponsors & Collaborators

  • State University of New York at Buffalo

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-28
Primary Completion
2018-12-31
Completion
2019-04-21
FDA Device
Yes

Countries

  • United States

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 NCT03149042 on ClinicalTrials.gov