Evaluation of the STARFlex® Septal Closure System in Patients With a Stroke or TIA Due to the Possible Passage of a Clot of Unknown Origin Through a Patent Foramen Ovale (PFO)
Status unconfirmed · Phase 2/Phase 3
Conditions studied: Patent Foramen Ovale, Stroke, Ischemic Attack, Transient
In brief
The primary objective of the study is to determine whether the STARFlex® septal closure system will safely and effectively prevent a recurrent embolic stroke/transient ischemic attack (TIA) and mortality in patients with a PFO and to demonstrate superiority of the STARFlex® device compared to best medical therapy.
Key facts
- Study ID
- NCT00201461
- Run by
- NMT Medical
- People needed
- 900
- Starts
- 2003-06-01
- Expected to finish
- 2010-04-01
- Last updated by the study team
- 2008-12-30
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
Where it is running
- The Cleveland Clinic Foundation — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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