Angiogram Based Fractional Flow Reserve FFRangio - A Validation Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03005028

Enrollment

184

Registered

2016-12-29

Start date

2015-01-31

Completion date

2016-03-15

Last updated

2018-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CAD - Coronary Artery Disease

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Israel

Outcome results