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Radiographic Imaging Validation and EvALuation for Angio iFR (ReVEAL iFR)

NCT03857503 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 441

Last updated 2021-04-01

No results posted yet for this study

Summary

The Philips Angio-iFR medical software device is intended to provide information on the functional significance of a coronary artery lesion to provide guidance on diagnostic decisions similar to that obtained through invasive measures of iFR and FFR. The software application uses the vessel geometry obtained from a coronary angiographic image together with a lumped parameter physiological model to provide the associated iFR and FFR estimates.

Conditions

Interventions

DIAGNOSTIC_TEST

iFR

Patients will undergo standard of care diagnostic coronary angiography using established invasive physiological criteria for iFR and FFR to aid in clinical decision making for coronary revascularization. Angiograms will be made in at least two projections, and the treating physician will record his/her estimation of stenosis severity. Resting iFR and Pd/Pa measures will then be made distal to the target lesion; adenosine will be administered, and the FFR measures will be made without moving the wire. An iFR pullback will then be made after hyperemia as abated. Patients will be treated or deferred from treatment based on physician decision aided by the iFR measures.

Sponsors & Collaborators

  • Volcano Corporation

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2021-03-12
Completion
2021-03-12

Countries

  • United States
  • Germany
  • Ireland
  • Japan
  • Netherlands
  • Spain
  • United Kingdom

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 NCT03857503 on ClinicalTrials.gov