NCT00600327

Carotid Artery Revascularization Using the Boston Scientific EPI Filter Wire EZ™ and the EndoTex™ NexStent™

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 488 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to demonstrate the safety of the NexStent for treatment of carotid artery lesions undergoing stenting with adjunctive use of the FilterWire distal embolic protection device. The rates will be compared to an Objective Performance Criterion (OPC) derived from historic data from high-risk patients undergoing surgical intervention with Carotid endarterectomy. Patients included in this study are those at higher risk for complications associated with CEA.

Conditions

• Transient Ischemic Attack
• Thromboembolic Stroke
• Stroke Prevention

Interventions

Type	Name	Description
DEVICE	EndoTex™ NexStent™	EndoTex™ NexStent™ is a flexible, fine mesh Nitinol stent used to treat patients that are at high risk of adverse events from carotid endarterectomy and require carotid revascularization of a target vessel that has a reference diameter between 4mm and 9mm and stenosis that is less than 30mm in length.
DEVICE	Filter Wire EZ™	EPI Fliter Wire EZ™ Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in coronary saphenous vein bypass grafts and carotid arteries.

Timeline

• Start date: 2001-12-01
• Primary completion: 2005-03-01
• Completion: 2007-06-01
• First posted: 2008-01-24
• Last updated: 2008-01-24

Locations

19 sites across 3 countries: United States, Argentina, Germany