NCT01233518

Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 285 (actual)
• Sponsor: HeartFlow, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center trial conducted at up to 20 US, Canadian, European and Asian centers designed to determine the diagnostic performance of CT-FLOW (the investigational technology) by coronary computed tomographic angiography (CCTA) for non-invasive assessment of the hemodynamic significance of coronary lesions, as compared to direct measurement of fractional flow reserve (FFR) during cardiac catheterization as a reference standard.

Detailed description

285 patient, prospective, multi-center trial conducted at up to 20 US, Canadian, European and Asian centers designed to determine the diagnostic performance of CT-FLOW (the investigational technology) by coronary computed tomographic angiography (CCTA) for non-invasive assessment of the hemodynamic significance of coronary lesions, as compared to direct measurement of fractional flow reserve (FFR) during cardiac catheterization as a reference standard

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	FFR	Fractional flow reserve measured during cardiac catheterization

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2010-11-03
• Last updated: 2021-02-09
• Results posted: 2021-01-22

Locations

1 site across 1 country: United States