Effects of Carotid Stent Design on Cerebral Embolization

Completed

Phase N/A Results

Trial Description

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).

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 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.

Conditions

Interventions

  • Carotid Artery Stenting Device
    Intervention Desc: Procedure in which the surgeon inserts a slender, metal-mesh tube, called a stent, which expands inside your carotid artery to increase blood flow in areas blocked by plaque.
  • Closed-cell stent Device
    Other Names: Carotid artery angioplasty
    Intervention Desc: Patients enrolled in this study arm underwent for carotid stenting using closed stent cell. The graft used in this groups was the Xact closed-cell stent. This type of device is rigid device with dense conposition of the nitinol rigns. Carotid stenting was used on standard fashion using filters as embolic protection device.
    ARM 1: Kind: Experimental
    Label: Closed-cell stent
  • Open-cell stent Device
    Other Names: Carotid artery angioplasty
    Intervention Desc: Patients enrolled in this study arm underwent for carotid stenting using open stent cell stents. This type of stent is a tube shaped graft composed of flexible nitinol rings. The device used in this group was the Acculinx open-cell stent. Stenting procedure eas performed on standard fashion.Filters were used as embolic protection device.
    ARM 1: Kind: Experimental
    Label: Open-cell stent

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be randomized to receive either open or closed stent placement. Comparison of the two types of carotid stent designs (open- vs. closed-cell) looking at the primary and secondary outcomes in 30 days after placement.

Outcomes

Type Measure Time Frame Safety Issue
Primary Transcranial doppler counts of micro-embolic signals in the ipsilateral middle cerebral artery.
Secondary Composite of any stroke, myocardial infarction or death; Subclinical cerebral embolization.
Secondary Composite of any stroke, myocardial infarction or death within 30 days after the carotid stenting procedure No
Secondary Subclinical cerebral embolization assessed by brain diffusion-weighted MRI within 24 hours after carotid artery stenting No

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