Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00196027
Status:
UNKNOWN
Last Update Posted:
2006-11-29
First Post:
2005-09-12
Brief Title:
Paradigm I Clinical Trial Study of the PFX Closure System in Subjects With Cryptogenic Stroke Transient Ischemia Attack or Paradoxical Embolism
Sponsor:
Cierra
Organization:
Cierra
Study Overview
Official Title:
Feasibility Study of the PFX Closure System in Subjects With Cryptogenic Stroke Transient Ischemia Attack or Paradoxical Embolism
Status:
UNKNOWN
Status Verified Date:
2006-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to demonstrate the safety of the PFX Closure System when utilized for patients with patent foramen ovale PFO suffering from cryptogenic stroke transient ischemic attacks or paradoxical embolism
Detailed Description:
Patent Foramen Ovale has been implicated in the etiology of paradoxical embolism cryptogenic stroke transient ischemic attack TIA and right to left gas embolism in severe decompression illness An association between patent foramen ovale and severe migraine headaches has also been reported Several implantable devices are being used for percutaneous closure of patent foramen ovale we propose to use a non-implantable system to safely effect closure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None