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NCT00600327 · ClinicalTrials.gov registry record · Phase 3
Carotid Artery Revascularization Using the Boston Scientific EPI Filter Wire EZ™ and the EndoTex™ NexStent™
A Phase 3 study, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 488
- Enrollment target
NCT00600327 is a Phase 3 study that has completed, run by Boston Scientific Corporation. The registered enrollment target is 488 participants.
The verdict
NCT00600327, a Phase 3 study, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 488 participants
- Enrollment target
Study Summary
The primary objective of this study is to demonstrate the safety of the NexStent for treatment of carotid artery lesions undergoing stenting with adjunctive use of the FilterWire distal embolic protection device. The rates will be compared to an Objective Performance Criterion (OPC) derived from historic data from high-risk patients undergoing surgical intervention with Carotid endarterectomy. Patients included in this study are those at higher risk for complications associated with CEA.
Interventions
- DEVICE EndoTex™ NexStent™
- DEVICE Filter Wire EZ™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 488 participants |
| Start Date | 2001-12 |
| Est. Completion | 2007-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00600327
The ClinicalTrials.gov registry entry for NCT00600327 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 488 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Scientific Corporation, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which EndoTex™ NexStent™ is the first listed.
NCT00600327 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00600327 about?
NCT00600327 is a clinical study titled "Carotid Artery Revascularization Using the Boston Scientific EPI Filter Wire EZ™ and the EndoTex™ NexStent™". The primary objective of this study is to demonstrate the safety of the NexStent for treatment of carotid artery lesions undergoing stenting with adjunctive use of the FilterWire distal embolic protection device. The rates will be compared to an Objective Performance Criterion (OPC) derived from his...
What is the current status of trial NCT00600327?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 488 participants. The study started on 2001-12. Estimated completion is 2007-06.
What interventions are being tested in trial NCT00600327?
The interventions under investigation include: EndoTex™ NexStent™ (DEVICE), Filter Wire EZ™ (DEVICE).
Who is sponsoring clinical trial NCT00600327?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
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