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

Resource links provided by NLM:


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
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
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014