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

Completed

Phase N/A Results

Update History

23 Jul '15
Trial was updated to "N/A."
12 Mar '14
A location was updated in Dendermonde.
New
The overall status was removed for AZ Sint Blasius Hospital, Department of Vascular Surgery.
A location was updated in Bad-Krozingen.
New
The overall status was removed for Universitaets Herzzentrum.
A location was updated in Berlin.
New
The overall status was removed for Ihre-Radiologen.de.
A location was updated in Dortmund.
New
The overall status was removed for Klinikum Dortmund GmbH.
A location was updated in Frankfurt.
New
The overall status was removed for CardioVascular Center Frankfurt.
A location was updated in Hamburg.
New
The overall status was removed for Hamburg University Cardiovascular Center.
A location was updated in Leipzig.
New
The overall status was removed for Herzzentrum and Park-Krankenhaus.
A location was updated in Munich.
New
The overall status was removed for Städtisches Klinikum München GmbH Klinikum Neuperlach.
A location was updated in Cotignola.
New
The overall status was removed for Villa Maria Cecilia Hospital.
A location was updated in Mirano.
New
The overall status was removed for Mirano Hospital.
24 May '13
A location was updated in Dortmund.
New
The overall status was removed for Klinikum Dortmund GmbH.
16 Feb '13
A location was updated in Dendermonde.
New
The overall status was removed for AZ Sint Blasius Hospital, Department of Vascular Surgery.
A location was updated in Dortmund.
New
The overall status was removed for Klinikum Dortmund GmbH.
A location was updated in Munich.
New
The overall status was removed for Städtisches Klinikum München GmbH Klinikum Neuperlach.
14 Feb '13
The eligibility criteria were updated.
New
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
Old
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 de-novo 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
A location was updated in Dortmund.
New
The overall status was removed for Klinikum Dortmund GmbH.
A location was updated in Frankfurt.
New
The overall status was removed for CardioVascular Center Frankfurt.
A location was updated in Hamburg.
New
The overall status was removed for Hamburg University Cardiovascular Center.
A location was updated in Leipzig.
New
The overall status was removed for Herzzentrum and Park-Krankenhaus.
A location was updated in Cotignola.
New
The overall status was removed for Villa Maria Cecilia Hospital.
A location was updated in Mirano.
New
The overall status was removed for Mirano Hospital.