Effects of Cerebral Protection With Filters vs. Flow Reversal on Cerebral Embolization After Carotid Artery Stenting
|ClinicalTrials.gov Identifier: NCT01414387|
Recruitment Status : Terminated (Therapy for carotid disease has recently changed. Carotid stenting is now restricted to high risk patients that are not eligible for the study.)
First Posted : August 11, 2011
Last Update Posted : August 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Carotid Artery Disease Stroke||Procedure: Carotid filter Procedure: Carotid reversal of flow||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effects of Cerebral Protection With Filters vs. Flow Reversal on Cerebral Embolization After Carotid Artery Stenting|
|Actual Study Start Date :||October 2011|
|Actual Primary Completion Date :||February 12, 2016|
|Actual Study Completion Date :||February 12, 2016|
Active Comparator: Carotid filter
For this intervention group, patients will receive FDA-approved filter devices for cerebral embolic protection during carotid artery stenting intervention.
Procedure: Carotid filter
Patients randomized to this group will receive filter devices to prevent cerebral embolization during carotid stenting, assessed by intraoperative transcranial Doppler and postoperative cerebral DW-MRI.
The filter used for this trial is the RX accunet embolic protection system manufactured by abbott.
Active Comparator: Carotid reversal of flow
For this intervention group, patients will receive reversal of flow with the FDA-approved Gore Neuroprotection System for cerebral protection during carotid artery stenting.
Procedure: Carotid reversal of flow
On the flow reversal arm two type of devices will be used. The first is the Gore flow reversal system, manufactured by LW Gore and the second device is the IVANTEC MoMa Ultra Embolic protection device, manufatured by IVANTEC.
- Cerebral embolization [ Time Frame: Within 24 hours post carotid artery stenting ]Number of cerebral macro and microembolic events assessed as the number of new ipsilateral brain lesions detected by brain diffusion-weighted magnetic resonance imaging within 24 hours post carotid artery stenting and number of intraoperative microembolic signals detected by transcranial Doppler in the middle cerebral artery ipsilateral to the procedure during carotid artery stenting.
- Any Stroke, TIA, MI or death [ Time Frame: Within 30 days after carotid artery stenting ]Occurrence of any stroke, transient ischemic attack (TIA), myocardial infarction, or death within 30 days after carotid artery stenting.
- Technical success of carotid artery stenting [ Time Frame: 4 weeks. ]
- Stent thrombosis [ Time Frame: within 30 days post procedure ]Thrombosis of carotid artery stent implanted during the index procedure, assessed within 30 days after procedure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01414387
|United States, Texas|
|Dallas VA Medical Center|
|Dallas, Texas, United States, 75216|
|Principal Investigator:||Carlos H Timaran, MD||Dallas VA Medical Center|