An interventional study of PFx Closure System in PFO, Stroke and Transient Ischemic Attack, sponsored by Cierra. Suspended at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2007-12-21.
Sponsored by Cierra · Not applicable, Interventional, and Treatment
The primary object of this study is to demonstrate the continued safety and performance of the PFx Closure System when utilized for patients with PFOs suffering from cryptogenic stroke, transient ischemic attack, migraine or decompression illness.
7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's planned enrollment of 200 is above the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →Cierra is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
PFO with one or more of:
Exclusion Criteria:
PFO closure at 6 months post procedure.
Time frame: 6 months post procedure
PFO closure at 30 days and 12 months post procedure. AE event rate for all subjects. Measurement of migraine severity or frequency at 6 and 12 months post procedure for subjects enrolled due to diagnosis of migraine.
Time frame: 30 days; 6 and 12 months
This study is suspended, as verified in Dec 2007. You cannot join it, but the record below documents what was studied.
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Cierra