Carotid Artery Revascularization Using the Boston Scientific EPI Filter Wire EZ™ and the EndoTex™ NexStent™ (CABERNET)
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ClinicalTrials.gov Identifier: NCT00600327 |
Recruitment Status :
Completed
First Posted : January 24, 2008
Last Update Posted : January 24, 2008
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Sponsor:
Boston Scientific Corporation
Information provided by:
Boston Scientific Corporation
Tracking Information | ||||||||||
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First Submitted Date ICMJE | January 14, 2008 | |||||||||
First Posted Date ICMJE | January 24, 2008 | |||||||||
Last Update Posted Date | January 24, 2008 | |||||||||
Study Start Date ICMJE | December 2001 | |||||||||
Actual Primary Completion Date | March 2005 (Final data collection date for primary outcome measure) | |||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | |||||||||
Change History | No Changes Posted | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
Descriptive Information | ||||||||||
Brief Title ICMJE | Carotid Artery Revascularization Using the Boston Scientific EPI Filter Wire EZ™ and the EndoTex™ NexStent™ | |||||||||
Official Title ICMJE | Carotid Artery Revascularization Using the Boston Scientific EPI Filter Wire EZ™ and the EndoTex™ NexStent™ | |||||||||
Brief 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. | |||||||||
Detailed Description | Not Provided | |||||||||
Study Type ICMJE | Interventional | |||||||||
Study Phase ICMJE | Phase 3 | |||||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: 1
Interventions:
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Publications * | Hopkins LN, Myla SV, Grube E, Eles G, Dave R, Jaff MR, Allocco DJ. Carotid artery revascularisation in high-surgical-risk patients with the NexStent and the FilterWire EX/EZ: 3-year results from the CABERNET trial. EuroIntervention. 2010 Apr;5(8):917-24. doi: 10.4244/. | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||
Recruitment Status ICMJE | Completed | |||||||||
Actual Enrollment ICMJE |
488 | |||||||||
Original Actual Enrollment ICMJE | Same as current | |||||||||
Actual Study Completion Date ICMJE | June 2007 | |||||||||
Actual Primary Completion Date | March 2005 (Final data collection date for primary outcome measure) | |||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
Listed Location Countries ICMJE | Argentina, Germany, United States | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number ICMJE | NCT00600327 | |||||||||
Other Study ID Numbers ICMJE | S2209 | |||||||||
Has Data Monitoring Committee | No | |||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||
IPD Sharing Statement ICMJE | Not Provided | |||||||||
Responsible Party | Cheryl Fontana, Boston Scientific | |||||||||
Study Sponsor ICMJE | Boston Scientific Corporation | |||||||||
Collaborators ICMJE | Not Provided | |||||||||
Investigators ICMJE |
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PRS Account | Boston Scientific Corporation | |||||||||
Verification Date | January 2008 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |