Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00417963
Status:
COMPLETED
Last Update Posted:
2017-03-01
First Post:
2007-01-02
Brief Title:
ViVEXX Carotid Revascularization Trial VIVA
Sponsor:
C R Bard
Organization:
C R Bard
Study Overview
Official Title:
The ViVEXX Carotid Revascularization Trial VIVA for High Surgical Risk Patients With Extracranial Carotid Artery Stenosis Using the Bard ViVEXX Carotid Stent and Emboshield BareWire Rapid Exchange Embolic Protection System
Status:
COMPLETED
Status Verified Date:
2017-01
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:
To evaluate the safety and efficacy of the Bard ViVEXX Carotid Stent and Emboshield BareWire Rapid Exchange Embolic Protection System in the treatment of extracranial carotid artery stenosis in patients at high risk for carotid endarterectomy
Detailed Description:
Patients with clinically significant stenosis within the common andor internal carotid artery who are at high risk for carotid endarterectomy and are amenable to percutaneous treatment including embolic protection balloon angioplasty and the carotid stent placement
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