Safety and Performance Evaluation of WIRION™ EPD in Patients Undergoing Carotid Artery Stenting "WISE"

Completed

Phase N/A Results

Eligibility Criteria

Inclusion Criteria

- 18 years of age
- Anticipated patient life expectancy of at least 1 year
- Patient or authorized representative, signed a written Informed Consent form
- Patient is willing to comply with the protocol requirements
- Candidate for catheter-based therapy of a single stenosis located in the internal carotid artery (ICA) or the carotid bifurcation, suitable for treatment with a single FDA-approved stent with a carotid use indication
- Reference vessel diameter for intended filter location between 3.5mm and 6.0mm
- An adequate "landing zone" of at least 30mm
- Patients with severe symptomatic or asymptomatic carotid artery stenosis, to be ≥ 50% for symptomatic patients OR ≥ 80% for asymptomatic patients
- At least one high surgical risk criteria, either anatomical or co-morbid risk factors, as listed below:
Category I - Anatomical high risk factors
- Recurrent stenosis after endarterectomy
- Previous radical neck surgery or radiation therapy to the neck
- High cervical ICA lesions or CCA lesions at or above C2 or below the clavicle
- Spinal immobility of the neck
- Tracheostomy or tracheal stoma
- Any laryngeal nerve palsy and bilateral carotid artery stenosis
Category II - Co-morbid risk factors
- Contralateral carotid occlusion
- Unstable angina (Canadian Cardiovascular Society class III/IV)
- Congestive Heart Failure (New York Heart Association functional class III/IV) and/or known severe left ventricular dysfunction LVEF<30%
- Requires coronary artery bypass surgery, cardiac valve surgery, major vascular surgery, or abdominal aortic aneurysm repair 31-60 days post carotid stent procedure
- Recent MI (>72 hr and <4 weeks)
- Severe pulmonary disease with FEV1 of <30%
- CAD in ≥2 unrevascularized vessels with stenosis ≥70%
- Age ≥75 years
- Uncontrolled diabetes - Female patient with no child bearing potential or has negative pregnancy test within the previous 7 days and agrees to remain on birth control throughout the study

Exclusion Criteria

- Total occlusion or near-occlusion of the target vessel
- Severe lesion calcification
- Presence of an alternate source of emboli
- Presence of a filling defect, or angiographically visible thrombus, at target site
- A greater than 50% CCA lesion proximal to the target or a distal (intracranial) lesion more severe than the target lesion
- Evolving, acute or recent stroke within the last 30 days
- Major stroke with a residual neurological deficit that would confound neurologic assessment
- Vertebrobasilar insufficiency symptoms only
- Major operation 30 days before or after the index procedure
- Ipsilateral intracranial stenosis that requires treatment
- Any pre-existing stent in ipsilateral carotid artery, or placement of a stent in contralateral carotid within 30 days of the index procedure
- History of intracranial hemorrhage within 12 months
- Any condition that precludes proper angiographic assessment or prevents femoral arterial access
- Uncontrolled hypertension
- Contraindication to heparin and bivalirudin, aspirin, thienopyridines
- Known sensitivity to radiographic contrast media which cannot be controlled with pre-medication
- History or current indication of bleeding diathesis or coagulopathy
- Chronic renal insufficiency
- Carotid artery dissection or aortic arch anatomical anomalies
- Dementia or a neurological illness
- Patient is enrolled in another drug or device study protocol that has not reached its primary endpoint
- Severe pulmonary hypertension
- Intra-cranial pathology (e.g., tumor, AVM. aneurysm, etc) that would make study participation inappropriate or confound neurologic assessment