NCT04356027

FUnctional diagnoSIs of corONary Stenosis (FUSION)

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 312 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Coronary Artery Disease
• Coronary Stenosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-06-26
• Primary completion: 2021-10-15
• Completion: 2021-10-15
• First posted: 2020-04-21
• Last updated: 2025-02-21
• Results posted: 2025-02-21

Locations

28 sites across 1 country: United States