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Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (F.A.M.E.)

NCT00267774 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1005

Last updated 2017-11-13

Study results available
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Summary

In this multicenter, international study we are evaluating two approaches to determine which coronary artery narrowings require stent placement in patients with multivessel coronary artery disease. Patients will be randomized to an angiographic strategy, where only coronary angiography is used to determine which lesions to stent or to a pressure wire strategy where fractional flow reserve, an index measured with the pressure wire, will be used to determine which lesions to stent. The primary outcome will be major adverse cardiac events at 1 year. A secondary outcome will be cost-effectiveness.

Conditions

  • Coronary Arteriosclerosis

Interventions

DEVICE

Fractional flow reserve

PROCEDURE

Angio-guided PCI

Sponsors & Collaborators

Principal Investigators

  • Nico H Pijls · Catharina Ziekenhuis Eindhoven

  • William F Fearon · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2008-09-30
Completion
2015-09-30

Countries

  • United States
  • Netherlands

Study Locations

More Related Trials

Entities

Companies

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 NCT00267774 on ClinicalTrials.gov