Angiogram Based Fractional Flow Reserve FFRangio - A Validation Study

CathWorks

Status: Completed

Conditions: CAD - Coronary Artery Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT03005028

FFRAngio 1.0

Details and patient eligibility

About

In the present study we aim at validating the computation of FFRangio values from the angiogram by comparing them to measured wire-based FFR values, in a larger scale and in a completely blinded manner. Investigation of a wide range of users in various conditions may strengthen the reliability of the FFRAngio measurements.

Enrollment: 184 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female above 18 years old age which undergo FFR as part of their standard care
• TIMI Grade Flow is equal to 3
• LVEF larger than 45%.
• Subjects with multi-vessel coronary artery disease, with NSTEMI are allowed.

Exclusion criteria

• Contraindicated for FFR examination or adenosine administration
• STEMI
• CTO
• TIMI Grade Flow below 3
• Arteries supplying akinetic or severe hypokinetic territories
• Prior CABG on the study vessel
• Left Main stenosis, In-stent restenosis and Collaterals
• Diffused atherosclerosis diseases and tandem lesions
• Aorto-ostial lesion

Trial design

184 participants in 1 patient group

Control