Carotid Artery Disease
Conditions
Keywords
Carotid Artery Disease, Embolic Protection
Brief summary
Evaluate the safety and efficacy of the Protege Stent and Spider Device in the treatment of common and/or internal carotid artery stenoses for subjects that are high risk for carotid endarterectomy.
Interventions
DEVICEPROTÉGÉ® GPS™ and PROTÉGÉ® RX Carotid Stent Systems and Spider Embolic Protection Device
Carotid artery stenting with distal embolic protection.
Sponsors
Medtronic Endovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years and above * informed consent * for female subjects, not pregnant or planning on becoming pregnant * meet protocol defined anatomical or clinical high risk criteria
Exclusion criteria
* participation in another clincial study which may affect either the pre-procedure or follow-up results * prior stenting of the ipsilateral carotid artery * life expectancy less than twelve months * known allergy or intolerance of study medications or device materials * must not meet general or angiographic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Myocardial infarction, ipsilateral cerebrovascular accident, procedure-related contralateral CVA or death within 30 days of implantation; and ipsilateral CVA from 31 days to 1 year post-implantation | 30 days and one year |
Secondary
| Measure | Time frame |
|---|---|
| Ipsilateral CVA, procedure-related contralateral CVA or death with 30 days of implantation; and ipsilateral CVA from 31 days to 1 year post-implantation | 30 days and one year |
| Target lesion revascularization | one year |
| Target vessel revascularization | one year |
| Primary patency at one year (<70% stenosis as measured by duplex scan) | one year |
| Technical success (defined as the ability to deploy the filter, place the stent over the filter wire, and recapture the filter with the resulting residual stenosis <50%) | at implant |
Countries
United States
Outcome results
None listed