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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01132495
First received: May 20, 2010
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Other: Stenting plus OMT
Other: Standard of care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment Versus Optimal Medical Treatment Alone in Patients With Stable Coronary Artery Disease

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Major adverse cardiac event rate (MACE) [ Time Frame: 24 Month ] [ Designated as safety issue: Yes ]
    MACE: A composite of all cause death, documented MI, unplanned hospitalization leading to urgent revascularization.


Secondary Outcome Measures:
  • Overall MACE [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Non-urgent revascularization procedures, cost and cost effectiveness, functional class, number of anti-anginal medication, rate of non-urgent revascularization, and rate of cerebrovascular event.


Estimated Enrollment: 1832
Study Start Date: May 2010
Estimated Study Completion Date: January 2017
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
PCI plus OMT
PCI plus optimal medical treatment
Other: Stenting plus OMT
FFR guided PCI, plus OMT
OMT alone
Optimal medical treatment alone
Other: Standard of care
OMT alone

Detailed Description:

Prospective, multi-center, multi-national, multi-continental, randomized clinical trial.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with

    • stable angina or,
    • stabilized angina pectoris or,
    • atypical chest pain or no chest pain but with documented silent ischemia
  2. at least one stenosis is present of at least 50% in one major native epicardial coronary artery and supplying viable myocardium
  3. Eligible for PCI
  4. Signed written informed consent

Exclusion Criteria:

  1. Patients in whom the preferred treatment is CABG
  2. Patients with left main coronary artery disease requiring revascularization
  3. Patients with a recent STEMI or Non-STEMI
  4. Prior CABG
  5. Contra-indication to dual antiplatelet therapy
  6. LVEF < 30%
  7. Severe LV hypertrophy
  8. Planned need for concomitant cardiac surgery
  9. Extremely tortuous or calcified coronary arteries precluding FFR measurements
  10. A life expectancy of less than 2 years
  11. Age under 21
  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: NCT01132495

  Show 29 Study Locations
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Bernard De Bruyne, MD O.L.Vrouwzlekenhuis Hospital
  More Information

No publications provided by St. Jude Medical

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01132495     History of Changes
Other Study ID Numbers: 0904
Study First Received: May 20, 2010
Last Updated: March 14, 2014
Health Authority: Belgium: Ethics Committee

Keywords provided by St. Jude Medical:
Stable angina
angina pectoris
PCI
FAME
FAME II
FFR
Fractional Flow Reserve
Pressure wire

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

ClinicalTrials.gov processed this record on October 20, 2014