safety and performance evaluation of wirion™ epd in patients undergoing carotid artery stenting

Conditions: Carotid Artery Diseases; Stroke

Summary: the purpose of this study is to compare the safety and performance of wirion™ epd in patients undergoing carotid artery stenting to a performance goal based on an analysis of the results of previous us ide carotid stenting with embolic protection studies

patient registry procedures include: * clinical events committee (cec); responsibility for validating all reported primary safety outcomes * data safety monitoring board (dsmb); to review and evaluate safety data including serious adverse events * 100% data monitoring; to compare data entered into the registry * source data verification; to assess the accuracy, completeness of registry data by comparing the data to external data sources (e.g., medical records, paper or electronic case report forms). * standard operating procedures; to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis and reporting for adverse events. * sample size assessment to specify the number of participants and follow up duration. * data management plan; to address situations where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results * statistical analysis plan; describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan.

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

Keywords: carotid carotid artery stenting stent embolic protection atherosclerotic disease