NCT00594100

GORE Embolic Protection With Reverse Flow

The Embolic Protection With Reverse Flow Study of the GORE Neuro Protection System in Carotid Stenting of Subjects At High Risk for Carotid Endarterectomy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 245 (actual)
• Sponsor: W.L.Gore & Associates · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare the 30-day safety and efficacy of the GORE Flow Reversal System when used with approved carotid stents to an Objective Performance Criterion derived from distal embolic protection studies.

Detailed description

The GORE Flow Reversal System, manufactured by W. L. Gore \& Associates, Inc., was developed as a proximal occlusion device to reverse the flow of blood in the carotid artery. It is designed to achieve embolic protection prior to crossing the lesion in the majority of cases in order to minimize the possibility of an adverse event occurrence. The objective of this study is to assess the safety and effectiveness of the GORE Flow Reversal System when used to provide embolic protection during Carotid Artery Stent (CAS) procedures. Subjects diagnosed with carotid stenosis requiring revascularization and are at high risk for adverse events from CEA are eligible to participate.

Conditions

• Carotid Artery Stenosis

Interventions

Type	Name	Description
DEVICE	GORE Flow Reversal System (GFRS)	Carotid artery angioplasty and stenting with embolic protection

Timeline

• Start date: 2006-07-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2008-01-15
• Last updated: 2013-12-27
• Results posted: 2009-05-05

Locations

2 sites across 1 country: United States