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NCT03149042 · ClinicalTrials.gov registry record
Validation of a Computed Tomography (CT) Based Fractional Flow Reserve (FFR) Software Using the 320 Detector Aquilion ONE CT Scanner.
A clinical trial, sponsored by State University of New York at Buffalo.
- Completed
- Registry status
- 75
- Enrollment target
NCT03149042: Completed study, sponsored by State University of New York at Buffalo.
NCT03149042 is a clinical trial that has completed, run by State University of New York at Buffalo. The registered enrollment target is 75 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03149042 has completed, sponsored by State University of New York at Buffalo.
- COMPLETED
- Registry status
- 75 participants
- Enrollment target
Study Summary
Coronary Computed Tomography Angiography (CCTA) contrast opacification gradients and FFR-CT estimation can aid in the severity estimation of significant atherosclerotic lesions. Currently, FFR-CT algorithms can only be optimized using theoretical models and can only be validated in large multi-center clinical trials. Using patient specific 3D printed coronary phantoms would allow optimization of FFR-CT algorithms with a measured validation technique without the need for large clinical trials. Thus the investigators believe that this study will result in a FFR-CT algorithm/method with a better predictability for arterial lesion severity than those existing on the market today. Flow measurements will be compared with: CT-FFR for both patients and phantoms, angio lab FFR measurements and 30 days follow-up. This pilot clinical study includes \~50 patients over a year and half at GVI.
Primary Outcome
Patient CCTA images were imported into Vitrea segmentation software (Vital Images, Minnetonka, MN) for use in the research-based CT based FFR algorithm. The software analyzes four data volumes acquired a 70%, 80%, 90% and 99% of the R-R interval and computes the FFR based on the changes in vessel diameter and computational fluid dynamics. Within the algorithm, the aortic root and three main coronary arteries (LAD, LCX, and RCA) were automatically segmented, and then manually adjusted to obtain a
Interventions
- DIAGNOSTIC_TEST CCTA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2016-05-28 |
| Est. Completion | 2019-04-21 |
What the finished NCT03149042 record still lists
NCT03149042 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 75 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which CCTA is the first listed.
NCT03149042 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03149042 about?
NCT03149042 is a clinical study titled "Validation of a Computed Tomography (CT) Based Fractional Flow Reserve (FFR) Software Using the 320 Detector Aquilion ONE CT Scanner.". Coronary Computed Tomography Angiography (CCTA) contrast opacification gradients and FFR-CT estimation can aid in the severity estimation of significant atherosclerotic lesions. Currently, FFR-CT algorithms can only be optimized using theoretical models and can only be validated in large multi-cente...
What is the current status of trial NCT03149042?
This trial is currently completed. The enrollment target is 75 participants. The study started on 2016-05-28. Estimated completion is 2019-04-21.
What interventions are being tested in trial NCT03149042?
The interventions under investigation include: CCTA (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03149042?
This trial is sponsored by State University of New York at Buffalo, which has 243 total clinical trials registered on ClinicalTrials.gov.
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