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Sponsored by: |
Dallas VA Medical Center |
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Information provided by: | Dallas VA Medical Center |
ClinicalTrials.gov Identifier: | NCT00830232 |
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 symptomatic and asymptomatic extracranial carotid stenosis undergoing carotid artery stenting (CAS).
Condition | Intervention |
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Stroke Carotid Stenosis |
Device: closed-cell stent Device: Open-cell stent |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Effects of Carotid Stent Design on Cerebral Embolization |
Estimated Enrollment: | 40 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Closed-cell stent: Active Comparator |
Device: closed-cell stent
Closed-cell stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
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Open-cell stent: Active Comparator |
Device: Open-cell stent
Open-cell Stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
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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 are fatal, and more than 4,000,000 surviving stroke victims are affected by significant disability. Seventy-five percent of strokes occur in the distribution of the carotid arteries and are considered of a thromboembolic etiology, most of which originate in carotid lesions. Carotid artery stenting (CAS) with cerebral embolic protection is currently the preferred treatment of carotid stenosis in high risk surgical patients, i.e., those with significant comorbidities or a hostile neck from previous surgical procedures or radiation. Although several predictors of adverse outcomes after CAS have been identified, the effects of device characteristics, including stent design, on neurologic adverse events have not been established.
The proposed study will be a randomized prospective controlled trial designed to test the hypothesis that the implantation of closed-cell stents for carotid lesions in high-risk patients will be associated with a reduced perioperative cerebral microembolization as detected by transcranial Doppler, and reduced 30-day stroke, myocardial infarction, and death rates when compared with the implantation of open-cell stents.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Symptomatic patients (TIA or non-disabling stroke within 6 months of the procedure), with carotid stenosis
Exclusion Criteria:
United States, Texas | |
Dallas VA Medical Center | Recruiting |
Dallas, Texas, United States, 75216 | |
Contact: Carlos H Timaran, MD 214-857-1888 timaran1@msn.com | |
Principal Investigator: Carlos H. Timaran, MD |
Principal Investigator: | Carlos H Timaran, MD | Dallas VA Medical Center |
Responsible Party: | Dallas VA Medical Center ( James LePage, PhD/ ACOS for Research ) |
Study ID Numbers: | IRB#08-035 |
Study First Received: | January 26, 2009 |
Last Updated: | January 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00830232 History of Changes |
Health Authority: | United States: Federal Government |
Stroke Carotid stenosis stents |
Arterial Occlusive Diseases Carotid Stenosis Cerebral Infarction Stroke Vascular Diseases |
Central Nervous System Diseases Constriction, Pathologic Brain Diseases Carotid Artery Diseases Cerebrovascular Disorders |
Arterial Occlusive Diseases Carotid Stenosis Nervous System Diseases Stroke Vascular Diseases |
Central Nervous System Diseases Cardiovascular Diseases Brain Diseases Carotid Artery Diseases Cerebrovascular Disorders |