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NCT00478673 · ClinicalTrials.gov registry record · Phase 4
Post-Approval Study of the NexStent Carotid Stent System and the FilterWire EZ Embolic Protection System: SONOMA
A Phase 4 study, sponsored by Boston Scientific Corporation.
- Terminated
- Registry status
- Phase 4
- Development phase
- 298
- Enrollment target
NCT00478673: Clinical Trial Phase 4 study, sponsored by Boston Scientific Corporation.
NCT00478673 is a Phase 4 study that was terminated before completion, run by Boston Scientific Corporation. The registered enrollment target is 298 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00478673, a Phase 4 study, was terminated before completion, sponsored by Boston Scientific Corporation.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 298 participants
- Enrollment target
Study 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.
Primary Outcome
30-day major adverse events (MAEs) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Interventions
- DEVICE NexStent Carotid Stent System (Monorail Delivery System)
- DEVICE FilterWire EZ™ Embolic Protection System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 298 participants |
| Start Date | 2007-05 |
| Est. Completion | 2009-07 |
| Phase | Phase 4 |
Why NCT00478673 stopped before completion
NCT00478673 is an interventional study that assigns participants to a tested intervention. The registered 298 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 2 interventions - of which NexStent Carotid Stent System (Monorail Delivery System) is the first listed.
NCT00478673 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00478673 about?
NCT00478673 is a clinical study titled "Post-Approval Study of the NexStent Carotid Stent System and the FilterWire EZ Embolic Protection System: SONOMA". 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.
What is the current status of trial NCT00478673?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 298 participants. The study started on 2007-05. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00478673?
The interventions under investigation include: NexStent Carotid Stent System (Monorail Delivery System) (DEVICE), FilterWire EZ™ Embolic Protection System (DEVICE).
Who is sponsoring clinical trial NCT00478673?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00478673's enrollment target sits among peer trials
298 292nd of 2000 higher than 1,709 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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