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Future REvascularization
Evaluation in patients with
Diabetes mellitus:
Optimal management of Multivessel
disease
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| Sponsor: |
National Heart, Lung and Blood Institute (NHLBI),
a division of the National Institutes of Health (NIH) |
Principal Investigator
and
Clinical Coordinating Center: |
Valentin Fuster, MD, PhD
Mount Sinai School of Medicine
One Gustave L. Levy Place
New York, NY 10029 USA
Tel: 212.241.7911
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| Data Coordinating Center: |
New England Research Institutes, Inc.
9 Galen Street
Watertown, MA 02472 USA
Tel: 617.923.7747
Fax: 617.673.9546
Email: FREEDOM@neriscience.com |
| Study Objective: |
To evaluate whether percutaneous coronary intervention
with drug-eluting stenting (PCI/DES) is as effective as standard of care,
coronary artery bypass surgery (CABG). |
| Subject Population: |
1900 adults with diabetes mellitus (Type 1
or Type 2) with angiographically confirmed multivessel CAD and morphology
amenable to either PCI/DES or CABG, with indication for revascularization
based upon symptoms or angina and/or objective evidence of myocardial
ischemia. |
| Clinical Centers: |
Clinical centers from North America, Europe, South America, India, Australia and New Zealand will participate in the FREEDOM Trial. Centers currently able to randomize include:
North America |
- Canada................19 sites
- USA......................50 sites
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South America |
- Argentina...............5 sites
- Brasil......................4 sites
- Colombia................2 sites
- Mexico....................1 site
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Europe |
- Czech Republic...... 2 sites
- France....................5 sites
- Germany.................7 sites
- Israel......................3 sites
- Italy........................3 sites
- Poland.....................6 sites
- Spain.......................6 sites
- Switzerland.............1 sites
- UK...........................4 sites
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Australasia |
- Australia................15 sites
- India........................6 sites
- New Zealand...........3 sites
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| Patient Enrollment: |
Patient recruitment began
in April 2005. To date, there have been 1901
patients randomized. |
Protocol Synopsis: |
Click here to download the protocol in PDF file.
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Helpful Links: |
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Last
updated:
March 31, 2010 5:06 PM
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