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FUnctional diagnoSIs of corONary Stenosis (FUSION) — FUSION  

Coronary Artery Disease Clinical Trial

Official title:
Validation of OCT-based FUnctional diagnoSIs of corONary Stenosis (FUSION)

Clinical Trial 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).

Clinical Trial Description

This study is a single-arm, prospective, multi-center study collecting OCT pullback images of lesions pre-percutaneous coronary intervention (PCI) and (optional) post-PCI procedure, and the corresponding pressure tracings and physiology indices. Up to 30 centers in the US will enroll approximately 310 patients. The expected duration of enrollment is approximately 15 months. The total duration of the clinical investigation is expected to be approximately 27 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04356027
Study type Observational
Source Abbott Medical Devices
Contact
Status Completed
Phase
Start date June 26, 2020
Completion date October 15, 2021
View Details
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