Angiogram Based Fractional Flow Reserve FFRangio - A Validation Study
Completed
- Conditions
- CAD - Coronary Artery Disease
- Registration Number
- NCT03005028
- Lead Sponsor
- CathWorks Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 184
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Lesion-specific image-based FFRAngio calculation, compared to the invasive FFR as the reference gold standard, with a blinded analysis yielding Bland- Altman of +/- 15% with 95% CI 1 hour Immediately following the invasive FFR procedure.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Rabin Medical Center
🇮🇱Petah Tiqva, Israel