Fractional Flow Reserve and Intravascular Ultrasound RelationShip STudy

NCT01153555 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 350

Last updated 2015-03-04

No results posted yet for this study

Summary

This is a multi-center, prospective registry of patients with intermediate coronary lesions defined as a stenosis of 40-80% by angiography. Approximately 300 patients will be enrolled into the study at sites in the United States and Europe. There will be no follow up beyond hospital discharge in this study. A sub-group of 30 patients will undergo Adenosine MRI. The investigators hypothesize that Intravascular Ultrasound Radiofrequency (IVUS RF) anatomical criteria, such as minimal luminal area, plaque burden and virtual histology plaque type, can predict physiological ischemia by Fractional Flow Reserve (FFR).

Conditions

Sponsors & Collaborators

  • Volcano Corporation

    lead INDUSTRY

Principal Investigators

  • Ron Waksman, MD · Medstar Health Research Institute

Eligibility

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

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-06-30
Completion
2012-06-30

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 NCT01153555 on ClinicalTrials.gov