CompletedNCT03005028Updated Feb 9, 2018

Angiogram Based Fractional Flow Reserve FFRangio - A Validation Study

An observational study in CAD - Coronary Artery Disease, sponsored by CathWorks Ltd.. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-09.

Sponsored by CathWorks Ltd. · Observational

Study type: Observational
Model: Cohort
Time perspective: Retrospective
Enrollment: 184
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

CAD - Coronary Artery Disease

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Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

This study will enroll male and female subjects above the age of 18, with stable angina who were referred to coronary angiography and have an FFR measurement in at least one coronary artery.

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

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

Observational model: Cohort
Time perspective: Retrospective
Enrollment: 184 participants (actual)
Patient registry: No

Groups and cohorts

Control

What researchers measure

Primary outcomes

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
Immediately following the invasive FFR procedure.
Time frame: 1 hour

Study locations

1 site

Rabin Medical Center
Petah Tiqva, Israel

References and documents

Publications

Pellicano M, Lavi I, De Bruyne B, Vaknin-Assa H, Assali A, Valtzer O, Lotringer Y, Weisz G, Almagor Y, Xaplanteris P, Kirtane AJ, Codner P, Leon MB, Kornowski R. Validation Study of Image-Based Fractional Flow Reserve During Coronary Angiography. Circ Cardiovasc Interv. 2017 Sep;10(9):e005259. doi: 10.1161/CIRCINTERVENTIONS.116.005259. PubMed 28916602 ↗

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03005028
Lead sponsor: CathWorks Ltd.
Responsible party: Sponsor
First posted: Dec 29, 2016
Start date: Jan 2015
Primary completion: Mar 15, 2016
Completion: Mar 15, 2016
Last update: Feb 9, 2018

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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