Diastolic Hyperemia Free Index for Assessment of Moderate Coronary Stenoses

NCT04019535 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 88

Last updated 2025-01-13

No results posted yet for this study

Summary

A total of 106 subjects will be enrolled at up to 3 sites. Initial enrollment will occur at Washington University only. After 15 subjects have been enrolled at the primary site and no serious adverse events or protocol events have occurred the additional sites will be trained and added to enrollment.

Conditions

Interventions

DEVICE

physiological assessment with Volcano Verrata pressure wire (iFR)

physiological assessment of the coronary lesion will be made with both iFR and dFR. all clinical decisions will be made based on the results of iFR

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY
  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Marc Sintek, MD · Washington University School of Medicine

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-22
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • United States

Study Locations

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Entities

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 NCT04019535 on ClinicalTrials.gov