Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00196040
Status:
COMPLETED
Last Update Posted:
2007-12-24
First Post:
2005-09-12
Brief Title:
The Paradigm II Trial PFX Closure System in Subjects With Cryptogenic Stroke Transient Ischemic Attack Migraine or Decompression Illness
Sponsor:
Cierra
Organization:
Cierra
Study Overview
Official Title:
Feasibility Study of the PFX Closure System in Subjects With Cryptogenic Stroke Transient Ischemic Attack Migraine or Decompression Illness
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
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 and efficacy of the PFX Closure System when utilized for patent foramen ovale PFO in patients suffering from cryptogenic stroke undetermined cause of stroke transient ischemic attack brief neurological dysfunction migraine or decompression illness
Detailed Description:
Patent Foramen Ovale has been implicated in the etiology of paradoxical embolism cryptogenic stroke transient ischemic attack 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