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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Stanford University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00267774
First received: December 19, 2005
Last updated: November 9, 2009
Last verified: November 2009
  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

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

Resource links provided by NLM:


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 ]

Estimated Enrollment: 1000
Study Start Date: January 2006
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
  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

No publications provided by Stanford University

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

Responsible Party: William F Fearon, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00267774     History of Changes
Other Study ID Numbers: 3933
Study First Received: December 19, 2005
Last Updated: November 9, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 23, 2014