CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 285 enrolled
Drug / intervention
FFRdevice
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.

Search/NCT01233518
NCT01233518N/ACompleted
CompareCT.gov

Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography

HeartFlow, Inc.·interventional·Posted Nov 3, 2010·Updated Feb 9, 2021

In Brief

A clinical study evaluating FFR for Coronary Artery Disease. Completed, enrolled 285 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease
CountriesUnited States
CollaboratorsBaim Institute for Clinical Research, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Minneapolis Heart Institute Foundation

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 3, 2010
Enrollment StartOct 1, 2010
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 15.7 years ago

Interventions

FFRdevice

Fractional flow reserve measured during cardiac catheterization