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FUnctional diagnoSIs of corONary Stenosis (FUSION)

NCT04356027 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 312

Last updated 2025-02-21

Study results available
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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).

Conditions

Interventions

PROCEDURE

ICA (Invasive Coronary Angiography)

Patients will undergo a Pre-PCI Angiography

PROCEDURE

OCT

OCT pullback images will be collected pre-PCI and (optional) post-PCI procedure

PROCEDURE

FFR

FFR will be measured

OTHER

VFR Analysis

VFR will be calculated offline using the OCT pullback images

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Allen Jeremias, MD · St. Francis Hospital,Roslyn,NY, United States

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-26
Primary Completion
2021-10-15
Completion
2021-10-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04356027 on ClinicalTrials.gov