Angiogram Based Fractional Flow Reserve FFRangio - A Validation Study
1 other identifier
observational
184
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2016
CompletedFirst Submitted
Initial submission to the registry
December 19, 2016
CompletedFirst Posted
Study publicly available on registry
December 29, 2016
CompletedFebruary 9, 2018
February 1, 2018
1.2 years
December 19, 2016
February 8, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
1 hour
Study Arms (1)
Control
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CathWorks Ltd.lead
Study Sites (1)
Rabin Medical Center
Petah Tikva, Israel
Related Publications (1)
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.
PMID: 28916602DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2016
First Posted
December 29, 2016
Study Start
January 1, 2015
Primary Completion
March 15, 2016
Study Completion
March 15, 2016
Last Updated
February 9, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share