Effects of Carotid Stent Design on Cerebral Embolization

Dallas VA Medical Center

Status: Completed

Conditions: Stroke; Carotid Stenosis

Treatments: Device: closed-cell stent (Xact stent); Device: Open-cell stent (Acculink carotid)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00830232

IRB#08-035

Details and patient eligibility

About

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).

Full 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 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 diffusion-weighted magnetic resonance imaging of the brain, and reduced 30-day stroke, myocardial infarction, and death rates when compared with the implantation of open-cell stents.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Closed-cell stent (Xact stent)

Active Comparator group

Description:

For patients randomized to the closed-cell stent group, the Xact closed-cell stents were used. The Xact stent is a FDA approved device.

Treatment:

Device: closed-cell stent (Xact stent)

Open-cell stent (Acculink carotid)

Active Comparator group

Description:

For patients randomized to the open-cell stent group, the Acculink carotid stent was used. The Acculink stent is a FDA approved device.

Treatment:

Device: Open-cell stent (Acculink carotid)