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

Stopped early · Phase 4

Conditions studied: Carotid Stenosis

In brief

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.

Key facts

Study ID

NCT00478673

Run by

Boston Scientific Corporation

People needed

298

Starts

2007-05-01

Expected to finish

2009-07-01

Last updated by the study team

2012-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• St. Luke's Medical Center — Phoenix, Arizona, United States
• Central Cardiology Medical Clinic — Bakersfield, California, United States
• Los Angeles Cardiology Associates — Los Angeles, California, United States
• ACS Research Group, Inc. — Mountain View, California, United States
• Hoag Memorial Hospital / Presbyterian — Newport Beach, California, United States
• Salinas Valley Memorial Healthcare System — Salinas, California, United States
• University of Connecticut Health Center — Farmington, Connecticut, United States
• JFK Medical Center — Atlantis, Florida, United States
• Northwest Medical Center — Margate, Florida, United States
• Baptist Cardiac and Vascular Institute, Baptist Hospital of Miami — Miami, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Piedmont Hospital — Atlanta, Georgia, United States
• Neurological Institute of Savannah — Savannah, Georgia, United States
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States
• Prairie Education & Research Cooperative — Springfield, Illinois, United States
• Northern Indiana Research Alliance — Fort Wayne, Indiana, United States
• The Indiana Heart Hospital — Indianapolis, Indiana, United States
• Terrebonne General Medical Center — Houma, Louisiana, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Willis Knighton Medical Center — Shreveport, Louisiana, United States
• Washington Adventist Hospital — Takoma Park, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Caritas St. Elizabeth's Medical Center — Brighton, Massachusetts, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• Huntsville Hospital Heart Center — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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