Effects of Carotid Stent Design on Cerebral Embolization

Completed · Not applicable

Conditions studied: Stroke, Carotid Stenosis

In brief

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).

Key facts

Study ID

NCT00830232

Run by

Dallas VA Medical Center

People needed

40

Starts

2008-12-01

Expected to finish

2012-02-01

Last updated by the study team

2020-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Dallas VA Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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