NCT00478673

Post-Approval Study of the NexStent Carotid Stent System and the FilterWire EZ Embolic Protection System: SONOMA

The NexStent® Carotid Stent System: A Post Market Approval Evaluation Study In Conjunction With the FilterWire EZ™ Embolic Protection System

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 298 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the SONOMA Registry is to confirm the safety of the NexStent® Carotid Stent System and FilterWire EZ™ Embolic Protection System in routine clinical practice and to identify rare or unanticipated device-related events that might occur.

Detailed description

The SONOMA Registry will enroll approximately 300 subjects at a maximum at 78 study centers.

Conditions

• Carotid Stenosis

Interventions

Type	Name	Description
DEVICE	NexStent Carotid Stent System (Monorail Delivery System)	Self-expanding carotid stent for treating patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization.
DEVICE	FilterWire EZ™ Embolic Protection System	Used 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: 2007-05-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2007-05-25
• Last updated: 2012-08-07
• Results posted: 2012-08-07

Locations

62 sites across 1 country: United States