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

Sponsored by:	Boston Scientific Corporation
Information provided by:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT00478673

Purpose

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.

Condition	Intervention	Phase
Extracranial Carotid Artery Stenosis	Device: NexStent Carotid Stent System (Monorail Delivery System) Device: FilterWire EZ™ Embolic Protection System	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	The NexStent® Carotid Stent System: A Post Market Approval Evaluation Study In Conjunction With the FilterWire EZ™ Embolic Protection System

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:

30-day rate of major adverse events (MAE); 12-month composite rate of major adverse events (MAE) and ipsilateral stroke events that occur within 31-365 days for all subjects. [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]

Enrollment:	300
Study Start Date:	May 2007
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Self-expanding carotid stent for treating patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization.

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.

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478673

Show 62 Study Locations

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

Principal Investigator:	Subbarao Myla, M.D.	Hoag Memorial Hospital
Study Director:	Pamela Grady, PhD	Boston Scientific Corporation

More Information

Additional Information:

Carotid Artery Stenting Information Website This link exits the ClinicalTrials.gov site

Publications:

Qureshi AI, Knape C, Maroney J, Suri MF, Hopkins LN. Multicenter clinical trial of the NexStent coiled sheet stent in the treatment of extracranial carotid artery stenosis: immediate results and late clinical outcomes. J Neurosurg. 2003 Aug;99(2):264-70.

Responsible Party:	Boston Scientific ( Ana Becker )
Study ID Numbers:	S2042, SONOMA
Study First Received:	May 24, 2007
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00478673 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Boston Scientific Corporation:

NexStent
FilterWire EZ
Boston Scientific

Carotid Artery
Carotid Endarterectomy
Carotid Revascularization

Study placed in the following topic categories:

Arterial Occlusive Diseases
Carotid Stenosis
Embolism
Vascular Diseases
Central Nervous System Diseases

Constriction, Pathologic
Brain Diseases
Carotid Artery Diseases
Cerebrovascular Disorders

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Carotid Stenosis
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases

Cardiovascular Diseases
Brain Diseases
Carotid Artery Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on May 07, 2009