Evaluation of the Roadsaver Stent Used in Conjunction With the Nanoparasol Embolic Protection System for Carotid Artery Stenosis

Status unconfirmed · Not applicable

Conditions studied: Carotid Artery Stenosis

In brief

A prospective, multicenter, single-arm, open label clinical study 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.

Key facts

Study ID: NCT02657707
Run by: Microvention-Terumo, Inc.
People needed: 295
Starts: 2016-04-21
Expected to finish: 2024-05-01
Last updated by the study team: 2023-02-28

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient is between >21 and ≤80 years of age.
Patient is willing and capable of complying with all study protocol requirements, including specified follow-up period and can be contacted by telephone.
Patient or authorized legal representative is willing to provide written informed consent prior to enrollment in study.
Patient should have been diagnosed with carotid artery stenosis and be considered a high operative risk for carotid endarterectomy.
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.
Patient has a target lesion located at the carotid bifurcation and/or proximal ICA.
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.
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:
Patient has a target lesion at or above the second vertebral body (level of jaw) or below the clavicle.
Patient has an inability to extend the head due to cervical arthritis or other cervical disorders.
Patient is status/post radiation therapy to the neck.
Patient has a prior head and neck surgery in the region of the carotid artery.
Patient has spinal immobility of the neck.
Patient has the presence of tracheostomy stoma.
Patient has laryngeal palsy or laryngectomy.
Patient has a hostile neck or surgically inaccessible lesion.
Patient has severe tandem lesions.
Co-morbid High Risk Conditions:
Patient is ≥70 years of age (maximum 80 years) at the time of enrollment.
Patient has NYHA Class III or IV congestive heart failure (CHF) with LVEF <35%.

You may not qualify if…

Patient has life expectancy of less than one year.
Patient is experiencing (or has experienced) an evolving, acute, or recent disabling stroke in the last 30 days.
Patient has anticipated or potential sources of emboli (e.g. known previously symptomatic patent foramen ovale (PFO), mechanical heart valve, or deep vein thrombosis (DVT) treated within 6 months) that are not adequately treated with antithrombotics for at least two weeks with documented coagulation parameters in the target therapeutic range.
Patient has atrial fibrillation.
Patient has had an acute myocardial infarction within 60 days prior to index procedure.
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.
Patient has a history of major ipsilateral stroke.
Patient has >60% carotid stenosis contralateral to the target lesion requiring treatment prior to completion of thes study-required 12 month follow-up.
Patient has a modified Rankin Scale of >2 or has another neurological deficit not due to stroke that may confound the neurological patient assessments.
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.
Patient has platelet count <100,000/μL.
Patient has known sensitivity to heparin or previous incidence of Heparin-Induced Thrombocytopenia (HIT) type II.
Patient has contraindication to standard of care study medications, including antiplatelet therapy.
Patient has known sensitivity to contrast media that cannot be adequately controlled with premedication.
Patient has known bleeding diathesis or hypercoagulable state or refuses blood transfusions.
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, cerebral vascular disease [microangiopathy or large vessel], etc.) or would confound neurological evaluation.
Patient had intracranial hemorrhage within the last 90 days.
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.
Patient suffers from confusion or dementia or is unable or unwilling to cooperate with the study requirements and/or follow-up procedures.
Patient has a known, unresolved history of drug use or alcohol dependency.
Patient has an active infection.
Patient has renal failure and/or is on dialysis.
Patient has documented uncontrolled diabetes.
Patient is pregnant.
Angiographic Exclusion Criteria

Where it is running

Abrazo Arizona Heart Hospital — Phoenix, Arizona, United States
St. Luke's Medical Center — Phoenix, Arizona, United States
Yavapai Regional Medical Center — Prescott, Arizona, United States
Kaiser Permanente - Los Angeles — Los Angeles, California, United States
San Diego VA Medical Center — San Diego, California, United States
Radiology Imaging Associates — Denver, Colorado, United States
Swedish Medical Center — Englewood, Colorado, United States
Yale University School of Medicine — New Haven, Connecticut, United States
MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
Lyerly Baptist Neurosurgery — Jacksonville, Florida, United States
Kaiser Permanente Moanalua Medical Center - Specialty Clinic — Honolulu, Hawaii, United States
Prairie Education & Research Cooperative — Springfield, Illinois, United States
Baptist Health Lexington — Lexington, Kentucky, United States
Bryan Heart — Lincoln, Nebraska, United States
Darthmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
Overlook Medical Center — Summit, New Jersey, United States
Albany Medical College — Albany, New York, United States
University of Buffalo — Buffalo, New York, United States
Icahn School of Medicine at Mount Sinai — New York, New York, United States
Columbia University Medical Center — New York, New York, United States
Feinstein Institute for Medical Research — New York, New York, United States
Stony Brook University Medical Center — Stony Brook, New York, United States
NC Heart and Vascular Research / Rex Hospital — Raleigh, North Carolina, United States
Novant Health Forsyth Medical Center — Winston-Salem, North Carolina, United States
University Hospital — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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