Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure

Completed · Phase 3

Conditions studied: Carotid Artery Disease

In brief

The purpose of this study is to obtain and establish the safety and efficacy of The MICHI™ Neuroprotection System with Filter (MICHI™ NPS+f) for providing cerebral embolic protection during angioplasty and stenting procedures in carotid arteries. The MICHI NPS+f also facilitates access to the carotid and neuro anatomy for the introduction of therapeutic or diagnostic endovascular devices and/or agents. It will be used in conjunction with a FDA approved carotid artery stent for the treatment of carotid artery disease.

Key facts

Study ID

NCT01685567

Run by

Silk Road Medical

People needed

219

Starts

2012-11-01

Expected to finish

2016-07-01

Last updated by the study team

2017-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient must meet one of the following criteria regarding neurological symptom status and degree of stenosis:
• Symptomatic: Stenosis must be greater than or equal to 50% as determined by angiogram and the patient has a history of stroke (minor or non-disabling), TIA and/or amaurosis fugax within 180 days of the procedure.
• Asymptomatic: Stenosis must be greater than or equal to 70% as determined by angiogram without any neurological symptoms within the prior 180 days.
• Target vessel must meet diameter requirements for stent (refer to selected stent IFU for diameter requirements).
• Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA).
• Patient is greater or equal to 18 years of age.
• Patient has no childbearing potential or has a negative pregnancy test within one week prior to the study procedure.
• Patient understands the nature of the procedure and has provided a signed informed consent using a form that has been reviewed and approved by the Investigational Review Board/Ethics Committee of the respective clinical site prior to the procedure. This will be obtained prior to participation in the study.
• Patient is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.
• Patient meets at least one of the anatomic or clinical high-risk criteria.

You may not qualify if…

• Patient has chronic atrial fibrillation.
• Patient has had any episode of paroxysmal atrial fibrillation within the past 6 months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation.
• Patient has an evolving stroke.
• Patient has severe dementia.
• Patient has a history of spontaneous intracranial hemorrhage within the past 12 months.
• Patient has had a recent (<7 days) stroke of sufficient size (on CT or MRI) to place him or her at risk of hemorrhagic conversion during the procedure.
• Patient had hemorrhagic transformation of an ischemic stroke within the past 60 days.
• Patient has active bleeding diathesis or coagulopathy or will refuse blood transfusion.
• Patient had or will have CABG, endovascular stent procedure, valve intervention or vascular surgery within 30 days before or after the intervention.
• Patient has had a recent GI bleed that would interfere with antiplatelet therapy.
• Life expectancy of < 12 months post procedure.
• Patient has history of intolerance or allergic reaction to any of the study medications or stent materials (refer to stent IFU), including aspirin (ASA), ticlopidine, clopidogrel, prasugrel, statin or contrast media (that can't be pre medicated). Patients must be able to tolerate statins and a combination of ASA and ticlopidine, ASA and clopidogrel or ASA and prasugrel.
• Myocardial Infarction within 72 hours prior to the intervention.
• Presence of a previous placed intravascular stent in target vessel or the planned arteriotomy site.
• Patient has had neurologic illnesses within the past two years characterized by fleeting or fixed neurologic deficit which cannot be distinguished from TIA or stroke (e.g. partial or secondarily generalized seizures, complicated or classic migraine, tumor or other space-occupying brain lesions, subdural hematoma, cerebral contusion or other post-traumatic lesions, intracranial infection, demyelinating disease, moderate to severe dementia, or intracranial hemorrhage).
• Patient with a history of major stroke (CVA or retinal embolus) with major neurological deficit likely to confound study endpoints within 1 month of index procedure.
• Patient has Hgb <10 g/dl, platelet count <125,000/μl, uncorrected INR >1.5, bleeding time >1 minute beyond upper limit normal, or heparin-associated thrombocytopenia.
• Patient has an intracranial tumor.
• Patient is actively participating in another drug or device trial (IND or IDE) that has not completed the required protocol follow-up period.
• Patient has inability to understand and cooperate with study procedures or provide informed consent.
• Occlusion or [Thrombolysis In Myocardial Infarction Trial (TIMI 0)] "string sign" >1cm of the ipsilateral common or internal carotid artery.
• Patient has vertebrobasilar insufficiency symptoms only, without clearly identifiable symptoms referable to the study carotid artery.
• Knowledge of cardiac sources of emboli.e.g. left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, calcific aortic stenosis, endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm, or left atrial myxoma).
• Recently (<60 days) implanted heart valve (either surgically or endovascularly), which is a known source of emboli as confirmed on echocardiogram.
• Ostium of Common Carotid Artery (CCA) requires revascularization.

Where it is running

• Peter Morton UCLA Medical Center — Los Angeles, California, United States
• Florida Hospital — Orlando, Florida, United States
• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• McLaren Regional Medical Center — Flint, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Albany Medical Center — Albany, New York, United States
• University at Buffalo Neurosurgery, Inc — Buffalo, New York, United States
• Columbia University — New York, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• University Hospitals Case Medical Center and Case Western Reserve University School of Medicine — Cleveland, Ohio, United States
• Riverside Methodist Hospital — Columbus, Ohio, United States
• Jobst Vascular Institute — Toledo, Ohio, United States
• Oklahoma Heart — Oklahoma City, Oklahoma, United States
• Greenville Hospital System — Greenville, South Carolina, United States
• Cardiothoracic & Vascular Surgeons — Austin, Texas, United States
• Methodist Medical Center — Dallas, Texas, United States
• Dallas VA Medical Center — Dallas, Texas, United States
• Sentara Vascular Specialists — Norfolk, Virginia, United States
• Hospital Virgen de la Salud — Toledo, Spain

Full record on ClinicalTrials.gov

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