NCT00177346

A Randomized Trial of Carotid Artery Stenting With and Without Cerebral Protection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The primary objective of this study is to evaluate carotid artery stenting (CAS) with and without cerebral protection (CP) to determine if CP improves safety and effectiveness of CAS.

Detailed description

This study is a single center, prospective, randomized trial evaluating the safety and effectiveness of CAS with and without CP. The study population will be comprised of subjects with atherosclerotic, post endarterectomy restenotic or other obstructive lesions in native carotid arteries. Other carotid artery pathology not amenable to surgical repair (for example carotid artery dissection) will also be considered. Subjects at high risk for complications from standard CEA will be the target population for this study. High risk status will be confirmed by two physicians, one of whom is a vascular surgeon. Both symptomatic and asymptomatic subjects will be enrolled. This will ensure that the proportion of symptomatic subjects is the same in the two arms of the study. "Symptomatic" is defined in the exclusion criteria. The expected duration of this clinical trial is 3 years. In this study there are there are two arms that a subject may be randomized to: Group1: CAS with the use of the RX ACCUNET Group 2: CAS without the use of the RX ACCUNET This study has been designed to test whether the addition of CP enhances the safety and effectiveness of CAS.

Conditions

• Carotid Artery Stenosis

Interventions

Type	Name	Description
DEVICE	CAS with cerebral protection
DEVICE	CAS without cerebral protection

Timeline

• Start date: 2003-10-01
• Primary completion: 2007-01-01
• Completion: 2007-01-01
• First posted: 2005-09-15
• Last updated: 2016-01-07

Locations

1 site across 1 country: United States