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NCT04356027 · ClinicalTrials.gov registry record
FUnctional diagnoSIs of corONary Stenosis (FUSION)
A clinical trial, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- 312
- Enrollment target
NCT04356027: Completed study, sponsored by Abbott Medical Devices.
NCT04356027 is a clinical trial that has completed, run by Abbott Medical Devices. The registered enrollment target is 312 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04356027 has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- 312 participants
- Enrollment target
Study Summary
The purpose of the FUSION study is to validate the diagnostic performance of Virtual Flow Reserve (VFR) by comparing it against a reference standard, fractional flow reserve (FFR).
Primary Outcome
Sensitivity and specificity of the VFR compared with FFR each of which will be tested against a prespecified performance goal. FFR with a binary cut-off of 0.80 will be used as the reference standard for comparison. FFR or VFR value ≤ 0.80 will be considered positive (ischemia-causing), and FFR or VFR value \> 0.80 will be considered negative (non-ischemia-causing). Sensitivity is defined as the percentage of VFR positive lesions, in the group of FFR positive lesions. Sensitivity=TP/(TP+FN) x
Interventions
- PROCEDURE FFR
- PROCEDURE ICA (Invasive Coronary Angiography)
- PROCEDURE OCT
- OTHER VFR Analysis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 312 participants |
| Start Date | 2020-06-26 |
| Est. Completion | 2021-10-15 |
What the finished NCT04356027 record still lists
NCT04356027 is an observational study that tracks outcomes without assigning an intervention. The registered 312 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 4 interventions - of which FFR is the first listed.
NCT04356027 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04356027 about?
NCT04356027 is a clinical study titled "FUnctional diagnoSIs of corONary Stenosis (FUSION)". The purpose of the FUSION study is to validate the diagnostic performance of Virtual Flow Reserve (VFR) by comparing it against a reference standard, fractional flow reserve (FFR).
What is the current status of trial NCT04356027?
This trial is currently completed. The enrollment target is 312 participants. The study started on 2020-06-26. Estimated completion is 2021-10-15.
What interventions are being tested in trial NCT04356027?
The interventions under investigation include: FFR (PROCEDURE), ICA (Invasive Coronary Angiography) (PROCEDURE), OCT (PROCEDURE), VFR Analysis (OTHER).
Who is sponsoring clinical trial NCT04356027?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
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