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

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ClinicalTrials.gov Identifier: NCT00478673
Recruitment Status : Terminated (Enrollment was terminated in June 2008 due to market withdrawal of the NexStent Carotid Stent System.)
First Posted : May 25, 2007
Results First Posted : August 7, 2012
Last Update Posted : August 7, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Carotid Stenosis Device: NexStent Carotid Stent System (Monorail Delivery System) Device: FilterWire EZ™ Embolic Protection System Phase 4

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 298 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The NexStent® Carotid Stent System: A Post Market Approval Evaluation Study In Conjunction With the FilterWire EZ™ Embolic Protection System
Study Start Date : May 2007
Primary Completion Date : July 2009
Study Completion Date : July 2009
Arms and Interventions

Intervention Details:
    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.

Outcome Measures

Primary Outcome Measures :
  1. Number of Participants Who Experienced a 30-Day Major Adverse Event (MAE) [ Time Frame: 30 Days ]
    30-day major adverse events (MAEs) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.

  2. Number of Participants Who Experienced a 12-Month Major Adverse Event (MAE) [ Time Frame: 12 Months ]
    12-month major adverse events (MAEs) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure (see 30-Day MAE above), and ipsilateral stroke events that occur within 31-365 days post-procedure.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00478673     History of Changes
Other Study ID Numbers: S2042
SONOMA
First Posted: May 25, 2007    Key Record Dates
Results First Posted: August 7, 2012
Last Update Posted: August 7, 2012
Last Verified: July 2012

Keywords provided by Boston Scientific Corporation:
NexStent
FilterWire EZ
Boston Scientific
Carotid Artery
Carotid Endarterectomy
Carotid Revascularization

Additional relevant MeSH terms:
Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases