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

This study has been terminated.
(Enrollment was terminated in June 2008 due to market withdrawal of the NexStent Carotid Stent System.)
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00478673
First received: May 24, 2007
Last updated: July 2, 2012
Last verified: July 2012
  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
Carotid Stenosis
Device: NexStent Carotid Stent System (Monorail Delivery System)
Device: FilterWire EZ™ Embolic Protection System
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Boston Scientific Corporation:

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

  • Number of Participants Who Experienced a 12-Month Major Adverse Event (MAE) [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 298
Study Start Date: May 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
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.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00478673     History of Changes
Other Study ID Numbers: S2042, SONOMA
Study First Received: May 24, 2007
Results First Received: December 20, 2010
Last Updated: July 2, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014