Effects of Carotid Stent Design on Cerebral Embolization

NCT00830232 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-02-05

Study results available
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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).

Conditions

Interventions

DEVICE

closed-cell stent (Xact stent)

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.

DEVICE

Open-cell stent (Acculink carotid)

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.

Sponsors & Collaborators

  • Dallas VA Medical Center

    lead FED

Principal Investigators

  • Carlos H Timaran, MD · Dallas VA Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2011-12-31
Completion
2012-02-29

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00830232 on ClinicalTrials.gov