Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00201461
Status:
UNKNOWN
Last Update Posted:
2008-12-30
First Post:
2005-09-12
Brief Title:
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
Sponsor:
NMT Medical
Organization:
NMT Medical
Study Overview
Official Title:
A Prospective Multicenter Randomized Controlled Trial to Evaluate the Safety and Efficacy of the STARFlex Septal Closure System Versus Best Medical Therapy in Patients With a Stroke andor Transient Ischemic Attack Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale
Status:
UNKNOWN
Status Verified Date:
2008-11
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 the study is to determine whether the STARFlex septal closure system will safely and effectively prevent a recurrent embolic stroketransient ischemic attack TIA and mortality in patients with a PFO and to demonstrate superiority of the STARFlex device compared to best medical therapy
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CLOSURE I | None | None | None |