Carotid Artery Disease - CABANA
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Trial Sponsor
Boston Scientific
Principal Investigator
Gregory Mishkel, MD
Trial Name
A Carotid Stenting Boston Scientific Surveillance Program
(CABANA).
Purpose
The purpose of the Carotid Stenting Boston Scientific Surveillance Program ( CABANA) is to compile early clinical outcomes data for the company's Carotid Wallstent Monorail endoprosthesis used in conjunction with its FilterWire EZ embolic protection system in routine clinical practice.
Details
Patients with either ipsilateral or bilateral carotid artery disease (blockages in carotid arteries on one or both sides of the neck) that are considered at high risk for Carotid Endarterectomy, a surgical approach during which the artery is opened and plaque is scraped away.
Ages Eligible for Study
18 years or older
Genders Eligible for Study
Both
Inclusion Criteria
- Subject at high risk from Carotid Endarterectomy who requires carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease.
- Subjects with known blockage of the Carotid Arteries and/or symptoms of TIA (mini-stroke) or Stroke.
- 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 allergic to or can not tolerate Apsirin, Plavix or blood thinners
- Patients with uncorrected bleeding disorders
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