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Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography

NCT01233518 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 285

Last updated 2021-02-09

Study results available
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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.

Conditions

Interventions

DEVICE

FFR

Fractional flow reserve measured during cardiac catheterization

Sponsors & Collaborators

  • Baim Institute for Clinical Research

    collaborator OTHER

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    collaborator OTHER

  • Minneapolis Heart Institute Foundation

    collaborator OTHER

  • HeartFlow, Inc.

    lead INDUSTRY

Principal Investigators

  • James K Min, MD, FACC · Weill Medical College of Cornell University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-11-30
Completion
2011-11-30

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 NCT01233518 on ClinicalTrials.gov