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

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Trial Conditions
  • Extracranial Carotid Artery Stenosis
  • Carotid Stenosis
What is the purpose of this trial?

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.

Date & Status

Terminated

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

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.

Gender: Both
Steward Physician(s)
  • Subbarao Myla, M.D.
  • Pamela Grady, PhD
Facilities
  • St. Elizabeth's Medical Center - Terminated
Trial Interventions
Device
  • NexStent Carotid Stent System (Monorail Delivery System)
  • FilterWire EZ™ Embolic Protection System
Physician Researcher

Investigator Name:

  • Subbarao Myla, M.D.
  • Pamela Grady, PhD

Other Information

Sponsor: Boston Scientific Corporation
Phase: Phase 4
Trial ID: NCT00478673
Volunteers:  Not Accepting Healthy Volunteers

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