At a glance
ClinicalIndex Comparison RecordN/ACompleted· 312 enrolled
Drug / intervention
ICA (Invasive Coronary Angiography) +3 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Validation of OCT-based FUnctional diagnoSIs of corONary Stenosis (FUSION)
In Brief
An observational study evaluating ICA (Invasive Coronary Angiography), OCT, and 2 other interventions for Coronary Artery Disease and Coronary Stenosis. Completed, enrolled 312 participants across 28 sites.
Detailed 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).
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease, Coronary Stenosis
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
202120222023202420252026
First PostedApr 2020
Enrollment StartJun 2020
Primary CompletionOct 2021
TodayJul 2026
First PostedApr 21, 2020
Enrollment StartJun 26, 2020
Primary CompletionOct 15, 2021
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.2 years ago
Interventions
ICA (Invasive Coronary Angiography)procedure
Patients will undergo a Pre-PCI Angiography
OCTprocedure
OCT pullback images will be collected pre-PCI and (optional) post-PCI procedure
FFRprocedure
FFR will be measured
VFR Analysisother
VFR will be calculated offline using the OCT pullback images