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FAME II - Fractional Flow Reserve (FFR) Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Treatment (OMT) Verses OMT

NCT01132495 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1170

Last updated 2019-09-16

Study results available
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Summary

The overall purpose of the FAME II trial is to compare the clinical outcomes, safety and cost-effectiveness of FFR-guided PCI plus optimal medical treatment (OMT) versus OMT alone in patients with stable coronary artery disease.

Conditions

Interventions

OTHER

Stenting plus OMT

FFR guided PCI, plus OMT

OTHER

OMT

OMT alone

OTHER

Standard of care

FFR \> 0.80; treatment according to local practice

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Bernard De Bruyne, MD · O.L.Vrouwzlekenhuis Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2014-01-31
Completion
2015-05-31

Countries

  • United States
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Serbia
  • Sweden
  • 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 NCT01132495 on ClinicalTrials.gov