Carotid Artery Stenosis
Conditions
Keywords
carotid artery, carotid stenosis, carotid stenting, embolic protection
Brief summary
Multicenter, prospective, feasibility study designed to demonstrate the performance and safety of the Lumen Biomedical, Inc. FiberNet™ Embolic Protection System as an adjunctive device during carotid artery percutaneous intervention using the Guidant Acculink carotid stent in high surgical risk patients.
Interventions
DEVICEFiberNet Emboli Protection System
Sponsors
Lumen Biomedical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* One or more of the high surgical risk criteria. * Candidate for percutaneous stenting with target lesion located within common or internal carotid artery. * Symptomatic with atherosclerotic stenosis ≥ 50% or asymptomatic with atherosclerotic stenosis ≥ 70% of the carotid artery by NASCET Criteria.
Exclusion criteria
* Allergy to Heparin. * Myocardial infarction within the last 14 days. * Angioplasty or PTCA/PTA procedure within the past 48 hours. * Cardiac surgery within the past 60 days. * Planned invasive surgical procedure within 30 days. * Stroke within the past 14 days. * Transient ischemic neurological attack (TIA) or amaurosis fugax within the past 48 hours. * Intracranial stenosis that exceeded the severity of an extracranial stenosis. * Peripheral vascular disease of sufficient severity to prevent vascular access to the target lesion. * Total occlusion of the target vessel. * Lesion within 2cm of the ostium of the common carotid artery. * A stenosis that is known to be unsuitable for stenting because of one or more of: 1. Tortuous or calcified anatomy proximal or distal to the stenosis 2. Presence of visual thrombus 3. Pseudo occlusion ('string sign') * Serial lesions that requires more then one stent to cover entire lesion. * Procedural complication prior to introduction of the FiberNet device into the body.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of all death, all stroke and myocardial infarction within 30 days of the procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| All death and all stroke rates; Non-stroke neurological event rates; Technical success rates; Procedural success rates; Access site complication rates | — |
Countries
United States
Outcome results
None listed