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Completed

NCT Number: NCT01132495

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

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.

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Key information

Conditions

Coronary Artery Disease Angina Pectoris Angina, Stable Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Disease Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OLV Ziekenhuis, Aalst, Belgium

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stenting plus OMT

Other

FFR guided PCI, plus OMT

OMT

Other

OMT alone

Standard of care

Other

FFR > 0.80; treatment according to local practice

Primary outcomes

  1. Major Adverse Cardiac Event Rate (MACE)

    Time frame: 24 Month

    MACE: A composite of all cause death, documented MI, unplanned hospitalization leading to urgent revascularization.

Secondary outcomes

  1. Overall MACE

    Time frame: 3 years

    Individual components of the primary end point, cardiac death, and nonurgent revascularization

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment Versus Optimal Medical Treatment Alone in Patients With Stable Coronary Artery Disease

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
May 28, 2010
Registry last updated
Sep 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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