Trial Purpose and Description
To evaluate the safety and effectiveness of MicroVention, Inc. Roadsaver Carotid Stent System used in conjunction with the Nanoparasol® embolic protection system for the treatment of carotid artery stenosis in patients with elevated risk for adverse events following carotid endarterectomy.
Ages: 21 - 80 years
1.Patient is between >21 and ≤80 years of age. 2.Patient is willing and capable of complying with all study protocol requirements, including specified follow-up period and can be contacted by telephone. 3.Patient or authorized legal representative is willing to provide written informed consent prior to enrollment in study. 4.Females of childbearing potential must have documented negative pregnancy test within 10 days of Index Procedure and are to remain on an acceptable birth control method at least until the day of the Index Procedure. 5.Patient should have been diagnosed with carotid artery stenosis and be considered a high operative risk for carotid endarterectomy. 6.Patient is either: ◦Symptomatic with carotid stenosis ≥50% as determined by angiography using NASCET methodology. Symptomatic is defined as amaurosis fugax ipsilateral to the carotid lesion; TIA or non-disabling stroke within 180 days of the procedure within the hemisphere supplied by the target vessel; or ◦Asymptomatic with carotid stenosis ≥80% as determined by angiography using NASCET methodology.
7.Patient has a target lesion located at the carotid bifurcation and/or proximal ICA. 8.Patient has a single de novo or restenotic (post CEA) target lesion or severe tandem lesions close enough that can be covered by a single Roadsaver¿ stent. 9.Patients having a vessel with reference diameters between 3.0 mm and 9.0 mm at the target lesion. High Risk Inclusion Criteria For inclusion in the study, a patient must qualify in at least one anatomic or co-morbid high-risk condition, as shown below: Anatomic High Risk Conditions
10.Patient has surgically inaccessible lesion(s) at or above the level of C2 or below the clavicle. 11.Patient is status/post radiation therapy to the neck. 12.Patient has a prior head and neck surgery in the region of the carotid artery. 13.Patient has spinal immobility of the neck. 14.Patient has the presence of tracheostomy stoma. 15.Patient has laryngeal palsy or laryngectomy. 16.Patient has contralateral laryngeal nerve paralysis. 17.Patient has restenosis after a previous CEA. Co-morbid High Risk Conditions
18.Patient is ≥75 years of age (maximum 80 years) at the time of enrollment. 19.Patient has NYHA Class III or IV congestive heart failure (CHF). 20.Patient has chronic obstructive pulmonary disease (COPD) with FEV <30%. 21.Patient has a left ventricular ejection fraction (LVEF) ≤30%. 22.Patient has documented uncontrolled diabetes. 23.Patient has unstable angina with ECG changes. 24.Patient has had a recent myocardial infarction (≥72 hours, <30 days). 25.Patient has coronary artery disease with two or more vessels with ≥80% stenosis. 26.Patient has planned CABG or valve replacement surgery between 31-60 days after the CAS procedure. 27.Patient has contralateral total occlusion of the ICA.
Exclusion Criteria: 1.Patient has life expectancy of less than one year. 2.Patient is experiencing (or has experienced) an evolving, acute, or recent disabling stroke in the last 30 days. 3.Patient has anticipated or potential sources of emboli (e.g. atrial fibrillation, known previously symptomatic patent foramen ovale (PFO), mechanical heart valve, or DVT treated within 6 months) that are not adequately treated with anticoagulants for at least two weeks with documented coagulation parameters in the target therapeutic range. 4.Patient has had an acute myocardial infarction within 72 hours prior to index procedure. 5.Patient has had or plans to have any major surgical procedure (i.e. intraabdominal or intrathoracic surgery or any surgery/interventional procedure involving cardiac or vascular system) within 30 days of the index procedure. 6.Patient has a history of major, disabling ipsilateral stroke with residual deficit that may confound the neurological patient assessments. 7.Patient has known severe carotid stenosis contralateral to the target lesion requiring treatment within 30 days following the index procedure. 8.Patient has a modified Rankin Scale of >3 or has another neurological deficit not due to stroke that may confound the neurological patient assessments. 9.Patient has chronic renal insufficiency (serum creatinine ≥2.5 mg/dL) or has a history of severe hepatic impairment, malignant hypertension, and / or is morbidly obese. 10.Patient has platelet count <100,000/μL. 11.Patient has known sensitivity to heparin or previous incidence of Heparin-Induced Thrombocytopenia (HIT) type II. 12.Patient has contraindication to standard of care study medications, including antiplatelet therapy. 13.Patient has known sensitivity to contrast media that cannot be adequately controlled with pre-medication. 14.Patient has known bleeding diathesis or hypercoagulable state or refuses blood transfusions. 15.Patient has intracranial pathology that, in the opinion of the investigator, makes the patient inappropriate for study participation (e.g. brain tumor, AVM, cerebral aneurysm, etc.) or would confound neurological evaluation. 16.Patient had intracranial hemorrhage within the last 90 days. 17.Patient is currently enrolled in another investigational study protocol and has not completed its primary endpoint or that will confound the current study endpoints. Patients who are involved in the long-term surveillance of a clinical study are eligible. 18.Patient suffers from confusion or dementia or is unable or unwilling to cooperate with the study requirements and/or follow-up procedures. 19.The patient has a known, unresolved history of drug use or alcohol dependency.
A patient is not eligible for enrollment in the study if he/she meets any of the following angiographic exclusion criteria: 1.Patient has a total occlusion of the target carotid arteries (i.e., CCA or ICA). 2.Patient has a previously placed stent in the ipsilateral carotid artery. 3.Patient has severe lesion calcification or vascular tortuosity that may preclude the safe introduction of the sheath, guiding catheter, embolic protection system, or stent. 4.Patient has the presence of mobile filling defect felt or thrombus in target vessel. 5.Patient has occlusion or presence of "string sign" of the target vessel. 6.Patient has carotid (intracranial) stenosis located distal to target stenosis that is more severe than target stenosis. 7.Patient has >50% stenosis of the CCA proximal to the target lesion. 8.Patient has known mobile plaque or thrombus in the aortic arch.
Dates: 10/04/2017 - 08/31/2018
Last Updated: 12/01/2017
Study HIC#: 1602017265