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Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment

NCT05893498 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1924

Last updated 2026-03-10

No results posted yet for this study

Summary

To test whether FFRangio-guided treatment is non-inferior to conventional pressure wire-guided treatment in patients with coronary artery disease.

Conditions

  • Percutaneous Coronary Intervention

Interventions

DEVICE

FFRangio

A 3D image-base software device (CathWorks, Ltd, Kfar Saba, Israel) using three (3) angiographic views to provide a quantitative analysis of the functional significance of coronary lesions.

DEVICE

FFR or NHPR

Using an invasive pressure-wire to assess functional significance of coronary lesions either under hyperemic conditions (FFR) or utilizing Non-hyperemic pressure ratios (NHPR).

Sponsors & Collaborators

  • Cardiovascular Research Foundation, New York

    collaborator OTHER

  • CathWorks Ltd.

    lead INDUSTRY

Principal Investigators

  • Ajay J Kirtane, MD, SM · NewYork-Presbyterian/Columbia University Irving Medical Center

  • William F Fearon, MD · Stanford University

  • Allen Jeremias, MD, MSc · St. Francis Hospital & Heart Center

  • Martin B Leon, MD · NewYork-Presbyterian/Columbia University Irving Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-21
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Device
Yes

Countries

  • United States
  • Israel
  • Japan
  • Switzerland
  • United Kingdom

Study Locations

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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 NCT05893498 on ClinicalTrials.gov