Angiogram Based Fractional Flow Reserve FFRangio - A Validation Study
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-009100
NCT ID: NCT03005028
Sponsor Protocol Number: FFRAngio 1.0
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Joerg Herrmann, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available