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

Gardia Medical

Status

Completed

Conditions

Stroke

Carotid Artery Diseases

Treatments

Procedure: Carotid Artery Stent

Study type

Interventional

Funder types

Industry

Identifiers

NCT01783639

WIRION™ Pivotal Study (WISE)

WIRION Study Europe (WISE) (Other Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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