N/A
N=40
Effects of Carotid Stent Design on Cerebral Embolization
Stroke · Carotid Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT00830232 ↗Enrolled (actual)
40
Serious AEs
27.5%
Results posted
Mar 2014
Primary outcome: Primary: Transcranial Doppler Counts of Micro-embolic Signals in the Ipsilateral Middle Cerebral Artery. — 264; 339 Micro-emboli
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- closed-cell stent (Xact stent) (Device); Open-cell stent (Acculink carotid) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dallas VA Medical Center
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Transcranial Doppler Counts of Micro-embolic Signals in the Ipsilateral Middle Cerebral Artery. |
264; 339 | — |
| SECONDARY Composite of Any Stroke, Myocardial Infarction or Death |
— | — |
| SECONDARY Subclinical Cerebral Embolization Assessed by Brain Diffusion-weighted MRI |
— | — |
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 symptomatic and asymptomatic extracranial carotid stenosis undergoing carotid artery stenting (CAS).
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00830232). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.