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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
William Fearon, Stanford University
ClinicalTrials.gov Identifier:
NCT00267774
First received: December 19, 2005
Last updated: November 27, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention
Coronary Arteriosclerosis
Device: Fractional flow reserve
Procedure: Angio-guided PCI

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Major adverse cardiac events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cost effectiveness [ Time Frame: Index procedure ] [ Designated as safety issue: No ]

Enrollment: 1005
Study Start Date: January 2006
Study Completion Date: September 2015
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FFR guided PCI Device: Fractional flow reserve
Active Comparator: Angio-guided PCI Procedure: Angio-guided PCI

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:- at least 2 coronary lesions of 50% stenosis or greater in at least 2 major epicardial arteries

  • age>/=18

Exclusion Criteria:-- STEMI < 5 days ago or non-STEMI with CK > 1000 U/l < 5 days ago

  • Pregnancy
  • Extremely tortuous or calcified coronary arteries, or other technical conditions interfering with reliable coronary pressure measurement
  • Serious concomitant disease, decreasing life expectancy to <2 years
  • Previous coronary bypass surgery (CABG)
  • Contraindication for drug-eluting stent
  • Cardiogenic shock
  • Inability to give informed consent
  • Suspicion of significant left main (LM) stenosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00267774

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Netherlands
Catharina Hospital
Eindhoven, Netherlands
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Nico H Pijls Catharina Ziekenhuis Eindhoven
Principal Investigator: William F Fearon Stanford University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: William Fearon, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT00267774     History of Changes
Other Study ID Numbers: 3933 
Study First Received: December 19, 2005
Last Updated: November 27, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 27, 2016