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HeartFlowNXT - HeartFlow Analysis of Coronary Blood Flow Using Coronary CT Angiography

NCT01757678 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2017-11-14

Study results available
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Summary

To determine the diagnostic performance of FFRCT by coronary computed tomographic angiography (cCTA), as compared to cCTA alone, for non-invasive determination of the presence of a hemodynamically significant coronary lesion, using direct measurement of fractional flow reserve (FFR) during cardiac catheterization as a reference standard.

Conditions

Interventions

PROCEDURE

ICA (Invasive Coronary Angiography)

Per the protocol, patients will have an Invasive Coronary Angiography.

PROCEDURE

FFR (Fractional Flow Reserve)

Per the protocol, patients will have a Fractional Flow Reserve procedure.

PROCEDURE

cCTA (coronary computed tomography angiography)

Per the protocol, patients will have a coronary computed tomography angiography.

OTHER

FFRct Analysis (Fractional Flow Reserve Computed Tomography)

Per the protocol, patients will have a fractional flow reserve computed tomography.

Sponsors & Collaborators

  • Case Western Reserve University

    collaborator OTHER

  • HeartFlow, Inc.

    lead INDUSTRY

Principal Investigators

  • Bjarne Norgaard, MD · Aarhus University Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Denmark

Study Locations

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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 NCT01757678 on ClinicalTrials.gov