NCT01550835

Impact of Aspiration Thrombectomy During Carotid Stenting

Impact of Aspiration Thrombectomy During Carotid Stenting on New Ischemic Lesions Identified by Diffusion-Weighted Magnetic Resonance Imaging

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Fogarty Clinical Research Inc. · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether aspiration thrombectomy following carotid stent deployment will reduce the number of procedure related signals as identified by diffusion weighted MRI of the brain.

Detailed description

Studies have demonstrated that carotid artery stenting is a safe and effective alternative to carotid endarterectomy for high or standard risk patients with symptomatic stenosis. Despite the routine use of embolic protection devices, numerous studies have shown that carotid stenting is associated with a higher degree of intracranial emboli by diffusion-weighted MRI of the brain. A potential solution to minimize this effect is the use of aspiration prior to distal embolic protection removal.

Conditions

• Carotid Artery Stenosis

Interventions

Type	Name	Description
DEVICE	Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)	Standard of care use of an embolic protection device
DEVICE	Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)	Aspiration thrombectomy following stent deployment and prior to embolic protection device removal

Timeline

• Start date: 2012-02-01
• Primary completion: 2016-02-01
• First posted: 2012-03-12
• Last updated: 2015-04-21

Locations

2 sites across 1 country: United States