Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:09 AM
Study NCT ID:
NCT00196027
Status:
UNKNOWN
Last Update Posted:
2006-11-29
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
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:
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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: