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Participating in the CLOSURE I Trial for the StarFlex® Septal Occluder
System
The CLOSURE I Trial is for patients who have had a stroke or a TIA in the
last 3 months that is possibly related to a patent foramen ovale (PFO). It has
not been proven whether it is better for patients to simply take medications or
to have the PFO closed. Therefore patients who are eligible are encouraged to
enroll in this trial.
Patients who sign consent would be randomized to either best medical care
(aspirin, warfarin, or both) for stroke recurrence or to the StarFlex Septal
Closure System and have the PFO closed via a percutaneous approach.
Design
The study is a randomized controlled trial that is being conducted at 120
hospitals and medical centers including the Cleveland Clinic.
Additional information
Sponsor of the clinical trial/manufacturer of the StarFlex® Septal Occluder
NMT Medical, Inc.
Boston, MA 02210
www.nmtmedical.com
Principal Investigator of the trial and Cleveland Clinic physician
Anthony Furlan, MD 216-444-8638
Contact information
If your child has a patent foramen ovale and you would like more information
regarding this trial, please contact:
Cathy Sila, MD
Anthony Furlan, MD
Tracy Shenk, RN (Research Nurse)
All available at 216-444-8638 or toll-free 800-223-2273 ext. 48638
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