Status:
COMPLETED
Effects of Carotid Stent Design on Cerebral Embolization
Lead Sponsor:
Dallas VA Medical Center
Conditions:
Stroke
Carotid Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of the proposed study is to contrast the relative efficacy of closed-cell stents versus open-cell stents in preventing periprocedural cerebral embolization in high-risk patients with symptoma...
Detailed Description
Stroke is responsible for more than 10% of all deaths and much severe disability in developed countries. In the United States, approximately 600,000 new strokes are reported annually, of which 150,000...
Eligibility Criteria
Inclusion
- Subject is at high risk for carotid endarterectomy due to either anatomic or co-morbid conditions; AND
- Symptomatic patients (TIA or non-disabling stroke within 6 months of the procedure), with carotid stenosis ≥ 50% as diagnosed by angiography, using NASCET methodology (50); OR
- Asymptomatic patients with carotid stenosis ≥ 80% as diagnosed by angiography, using NASCET methodology
Exclusion
- Conditions that interfere with the evaluation of endpoints
- Subject has anticipated or potential sources of cardiac emboli
- Subject plans to have a major surgical procedure within 30 days after the index procedure.
- Subject has intracranial pathology that makes the subject inappropriate for study participation.
- Subject has a total occlusion of the ipsilateral carotid artery (i.e., CCA).
- Severe circumferential lesion calcification that may restrict the full deployment of the carotid stent.
- Carotid stenosis located distal to the target stenosis that is more severe than the target stenosis.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00830232
Start Date
December 1 2008
End Date
February 1 2012
Last Update
February 5 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Dallas VA Medical Center
Dallas, Texas, United States, 75216