Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287508
Status:
COMPLETED
Last Update Posted:
2008-10-17
First Post:
2006-02-01
Brief Title:
Emboshield and Xact Post Approval Carotid Stent Trial The EXACT Study
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
Emboshield and Xact Post Approval Carotid Stent Trial Using the Emboshield BareWire Rapid Exchange Embolic Protection System and Xact Rapid Exchange Carotid Stent System
Status:
COMPLETED
Status Verified Date:
2008-10
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 collect clinical outcome and device performance data on the FDA 510k-cleared Emboshield BareWire Rapid Exchange Embolic Protection System and FDA-approved Xact Rapid Exchange Carotid Stent System when used under commercial use conditions by a broad group of physicians entering the study with differing carotid artery stenting experiences
Detailed Description:
This is a multi-center observational single arm post-approval study enrolling the following study population
Subjects with neurological symptoms and 50 stenosis of the common or internal carotid artery by ultrasound or angiogram visual estimate or
Subjects without neurological symptoms and 80 stenosis of the common or internal carotid artery by ultrasound or angiogram visual estimate
The endpoint for the 1500 subjects enrolled will be a 30-day composite of death stroke and myocardial infarction MI
For the 500 subjects with 12 month follow-up the endpoint will be a composite of stroke death and MI at 30 days and ipsilateral stroke at 12 months 31-365 days
Subjects with neurological symptoms and 50 stenosis of the common or internal carotid artery by ultrasound or angiogram visual estimate or
Subjects without neurological symptoms and 80 stenosis of the common or internal carotid artery by ultrasound or angiogram visual estimate
The endpoint for the 1500 subjects enrolled will be a 30-day composite of death stroke and myocardial infarction MI
For the 500 subjects with 12 month follow-up the endpoint will be a composite of stroke death and MI at 30 days and ipsilateral stroke at 12 months 31-365 days
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