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: August 10, 2012

Last verified: August 2012

History of Changes

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:

MedlinePlus related topics: Angina Coronary Artery Disease

U.S. FDA Resources

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
Estimated 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:

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

Exclusion Criteria:

Patients in whom the preferred treatment is CABG
Patients with left main coronary artery disease requiring revascularization
Patients with a recent STEMI or Non-STEMI
Prior CABG
Contra-indication to dual antiplatelet therapy
LVEF < 30%
Severe LV hypertrophy
Planned need for concomitant cardiac surgery
Extremely tortuous or calcified coronary arteries precluding FFR measurements
A life expectancy of less than 2 years
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):

De Bruyne B, Pijls NH, Kalesan B, Barbato E, Tonino PA, Piroth Z, Jagic N, Mobius-Winckler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engström T, Oldroyd KG, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Jüni P, Fearon WF; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012 Sep 13;367(11):991-1001. Epub 2012 Aug 27.

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:	August 10, 2012
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 May 23, 2013

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