A Carotid Stenting Boston Scientific Surveillance Program - NCT00741091-53233 (Clinical Trial 382028)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy382028.aspx
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| City: |
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Milwaukee |
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State:
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WI |
| Zip Code: |
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53233 |
| Conditions: |
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Carotid Artery Disease |
| Purpose: |
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CABANA is a multicenter U.S. surveillance registry that will be conducted to compile early
clinical outcomes data for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in
routine clinical practice and to assess the adequacy of the Boston Scientific Corporation
(BSC) Carotid Stenting Training Program.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Subject at high risk for adverse events from carotid endarterectomy due to either
anatomic or comorbid conditions who requires carotid revascularization in the
treatment of ipsilateral or bilateral carotid artery disease.
- Subject with neurological symptoms and greater than or equal to 50% stenosis of the
common, internal carotid artery and/or the bifurcation by ultrasound or angiogram OR
- Subjects without neurological symptoms and greater than or equal to 80% stenosis of
the common, internal carotid artery and/or the bifurcation by ultrasound or
angiogram.
- Subject has a reference vessel diameter greater than or equal to 4.0 mm and less than
or equal to 9.0 mm at the target lesion and a vessel diameter distal to the target
lesion of greater than or equal to 3.5 mm and less than or equal to 5.5 mm as optimal
"landing zone" for placement of the FilterWire EZ System.
- Subject is willing and able to comply with all follow-up requirements.
- Subject has provided a signed informed consent prior to participation in the
Registry.
Exclusion Criteria:
- Patients in whom anticoagulant and/or antiplatelet therapy is contraindicated
- Patients with severe vascular tortuosity or anatomy that would preclude the safe
introduction of a guide catheter, sheath, embolic protection system or stent system
- Patients with uncorrected bleeding disorders
- Lesions in the ostium of the common carotid artery. |
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| Study is available at: |
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Aurora St. Luke's Medical Center
Milwaukee, WI 53233
United States
Primary Contact:
Tanvir Bajwa, MD
Email: dpayne@hrtcare.com
Phone: 414-219-7666
Secondary Contact:
Roni Pettigrew
Email: Veronica.Pettigrew@bsci.com
Phone: 651-581-4683 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 16, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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