Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00177346
Status:
COMPLETED
Last Update Posted:
2016-01-07
First Post:
2005-09-12
Brief Title:
A Randomized Trial of Carotid Artery Stenting With and Without Cerebral Protection
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
A Randomized Trial of Carotid Artery Stenting With and Without Cerebral Protection
Status:
COMPLETED
Status Verified Date:
2016-01
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:
The primary objective of this study is to evaluate carotid artery stenting CAS with and without cerebral protection CP to determine if CP improves safety and effectiveness of CAS
Detailed Description:
This study is a single center prospective randomized trial evaluating the safety and effectiveness of CAS with and without CP The study population will be comprised of subjects with atherosclerotic post endarterectomy restenotic or other obstructive lesions in native carotid arteries Other carotid artery pathology not amenable to surgical repair for example carotid artery dissection will also be considered Subjects at high risk for complications from standard CEA will be the target population for this study High risk status will be confirmed by two physicians one of whom is a vascular surgeon Both symptomatic and asymptomatic subjects will be enrolled This will ensure that the proportion of symptomatic subjects is the same in the two arms of the study Symptomatic is defined in the exclusion criteria The expected duration of this clinical trial is 3 years
In this study there are there are two arms that a subject may be randomized to
Group1 CAS with the use of the RX ACCUNET Group 2 CAS without the use of the RX ACCUNET This study has been designed to test whether the addition of CP enhances the safety and effectiveness of CAS
In this study there are there are two arms that a subject may be randomized to
Group1 CAS with the use of the RX ACCUNET Group 2 CAS without the use of the RX ACCUNET This study has been designed to test whether the addition of CP enhances the safety and effectiveness of CAS
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 |
|---|---|---|---|
| 0 | None | None | None |