Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00395785
Status:
TERMINATED
Last Update Posted:
2007-07-25
First Post:
2006-11-01
Brief Title:
Evaluation of the TriActiv ProGuard System During Carotid Artery Stenting
Sponsor:
Kensey Nash Corporation
Organization:
Kensey Nash Corporation
Study Overview
Official Title:
Protection During Carotid Stenting in High Risk Patients With the TriActiv ProGuard System
Status:
TERMINATED
Status Verified Date:
2007-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor elected to not pursue this indication for the study device
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of the TriActiv ProGuard System when used during a stent placement in a blockage within the carotid artery in patients considered to be at high risk for complications from surgical endarterectomy
Detailed Description:
Patients with certain anatomic or medical conditions have a greater risk of serious complications following carotid endarterectomy a surgical procedure that removes blockages in the carotid artery Recently these patients have been treated effectively with the implantation of a carotid stent a metallic mesh tube When implanting the carotid stent physicians use devices called embolic protection devices to prevent particles from the blockage from flowing up to the brain The TriActiv ProGuard System is an embolic protection device that uses a small balloon to temporarily stop blood flow within the diseased carotid artery while the stent is implanted Then the TriActiv ProGuard System removes any particles that may have been released from the blockage during stent implantation before blood flow is restored This study will evaluate the safety and efficacy of the TriActiv ProGuard System during carotid stent placement in patients who are considered to be at a high risk for complications from surgical endarterectomy
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