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

Boston Scientific

Status and phase: Terminated; Phase 4

Conditions: Carotid Stenosis

Treatments: Device: NexStent Carotid Stent System (Monorail Delivery System); Device: FilterWire EZ™ Embolic Protection System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00478673

S2042

SONOMA

Details and patient eligibility

About

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.

Full description

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

Enrollment: 298 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Candidates must be indicated for carotid stent placement as per NexStent Carotid Stent labeling located in the Directions for Use (DFU).

Exclusion criteria

• Subjects with contraindications as outlined in the DFU should be excluded from this registry.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)