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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Silk Road Medical
ClinicalTrials.gov Identifier:
NCT01685567
First received: September 10, 2012
Last updated: June 12, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention Phase
Carotid Artery Disease Device: MICHI NPS+f Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Prevention
Official Title: INVESTIGATION of FLOW ALTERED, SHORT TRANSCERVICAL CAROTID ARTERY STENTING in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE With Filter.

Resource links provided by NLM:


Further study details as provided by Silk Road Medical:

Primary Outcome Measures:
  • Hierarchical Composite of Stroke, Myocardial Infarction, and Death [ Time Frame: 30-day post-procedure ]
    The primary endpoint was a hierarchical composite of any stroke, myocardial infarction and death during a 30-day post-procedural period in the ITT (pivotal and extended enrollment) population comprised of subjects deemed to be high risk for complications from CEA.


Secondary Outcome Measures:
  • All Death (Non-hierarchical) [ Time Frame: 0 to 30 days ]
    The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.

  • All Myocardial Infarctions (Non-hierarchical) [ Time Frame: 0 to 30 days ]
    The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.

  • All Stroke (Non-hierarchical) [ Time Frame: 0 to 30 days ]
    The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.

  • Ipsilateral Stroke (Non-hierarchical) [ Time Frame: 31-365 days ]
    Data on ipsilateral stroke 31-365 days post procedure will be collected to provide additional supportive evidence of the safety of the device.


Enrollment: 219
Study Start Date: November 2012
Study Completion Date: July 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MICHI NPS+f
The MICHI™ NPS+f is a flow reversal circuit consisting of two proprietary sheaths connected by standard surgical tubing. The sheaths each have a standard hemostasis valve and sidearm. An in-line flow regulator allows the clinician to modify to the flow through the circuit (either high flow or low flow) in addition to permitting temporary cessation of flow.
Device: MICHI NPS+f
Cerebral protection with carotid flow reversal
Other Name: ENROUTE Transcarotid Neuroprotection System

Detailed Description:

Cerebral embolization during carotid artery stenting (CAS) can often precipitate severe adverse neurological effects. Most major clinical studies of CAS have used distal filters for cerebral protection and have compared the neurologic complication rates with those of carotid endarterectomy (CEA). Many currently available embolic protection devices, however, have limited efficacy in capturing microembolic debris that is liberated during stenting, pre-dilatation and post-dilatation. Distal protection systems are furthermore limited by the need to cross the lesion prior to deployment. Some studies have shown a relatively high incidence of cerebral infarction even when distal protection devices are employed.

Cerebral protection with carotid flow reversal is a method that was developed as an alternative to the use of distal protection devices. While novel in its approach, this method too has its limitations. Another technique developed employs carotid flow reversal prior to traversing the stenosis and can be accomplished by directly accessing the carotid anatomy without the use of the transfemoral approach. Major benefits to this method include a simpler route to the target lesion and the ability to perform the procedure on patients with severe carotid tortuosity and difficult aortic arch anatomy.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Target vessel must meet diameter requirements for stent (refer to selected stent IFU for diameter requirements).
  3. Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA).
  4. Patient is greater or equal to 18 years of age.
  5. Patient has no childbearing potential or has a negative pregnancy test within one week prior to the study procedure.
  6. 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.
  7. Patient is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.
  8. Patient meets at least one of the anatomic or clinical high-risk criteria.

Exclusion Criteria:

  1. Patient has chronic atrial fibrillation.
  2. Patient has had any episode of paroxysmal atrial fibrillation within the past 6 months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation.
  3. Patient has an evolving stroke.
  4. Patient has severe dementia.
  5. Patient has a history of spontaneous intracranial hemorrhage within the past 12 months.
  6. 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.
  7. Patient had hemorrhagic transformation of an ischemic stroke within the past 60 days.
  8. Patient has active bleeding diathesis or coagulopathy or will refuse blood transfusion.
  9. Patient had or will have CABG, endovascular stent procedure, valve intervention or vascular surgery within 30 days before or after the intervention.
  10. Patient has had a recent GI bleed that would interfere with antiplatelet therapy.
  11. Life expectancy of < 12 months post procedure.
  12. 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.
  13. Myocardial Infarction within 72 hours prior to the intervention.
  14. Presence of a previous placed intravascular stent in target vessel or the planned arteriotomy site.
  15. 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).
  16. 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.
  17. 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.
  18. Patient has an intracranial tumor.
  19. Patient is actively participating in another drug or device trial (IND or IDE) that has not completed the required protocol follow-up period.
  20. Patient has inability to understand and cooperate with study procedures or provide informed consent.
  21. Occlusion or [Thrombolysis In Myocardial Infarction Trial (TIMI 0)] "string sign" >1cm of the ipsilateral common or internal carotid artery.
  22. Patient has vertebrobasilar insufficiency symptoms only, without clearly identifiable symptoms referable to the study carotid artery.
  23. 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).
  24. Recently (<60 days) implanted heart valve (either surgically or endovascularly), which is a known source of emboli as confirmed on echocardiogram.
  25. Ostium of Common Carotid Artery (CCA) requires revascularization.
  26. Presence of extensive or diffuse atherosclerotic disease involving the proximal common carotid artery that would preclude the safe introduction of the study device.
  27. The patient has less than 5cm between the clavicle and bifurcation, as assessed by duplex Doppler ultrasound.
  28. Bilateral carotid stenosis if intervention is planned within 37 days of the index procedure.
  29. An intraluminal filling defect (defined as an endoluminal lucency surrounded by contrast, seen in multiple angiographic projections, in the absence of angiographic evidence of calcification) that is not associated with an ulcerated target lesion.
  30. Abnormal angiographic findings: ipsilateral intracranial or extracranial arterial stenosis greater in severity than the lesion to be treated, cerebral aneurysm > 5 mm, AVM (arteriovenous malformation) of the cerebral vasculature, or other abnormal angiographic findings.
  31. Patient has had a previous intervention in the ipsilateral proximal CCA.
  32. Patient has had a TIA or amaurosis fugax within 48 hours prior to the procedure.
  33. Patient has contralateral lateral recurrent, laryngeal or vagus nerve injury.
  34. Patient is otherwise unsuitable for intervention in the opinion of the investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01685567

Locations
United States, California
Peter Morton UCLA Medical Center
Los Angeles, California, United States, 90095
United States, Florida
Florida Hospital
Orlando, Florida, United States, 32804
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109-5967
McLaren Regional Medical Center
Flint, Michigan, United States, 48507
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
University at Buffalo Neurosurgery, Inc
Buffalo, New York, United States, 14203
Columbia University
New York, New York, United States, 10032
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44106
University Hospitals Case Medical Center and Case Western Reserve University School of Medicine
Cleveland, Ohio, United States, 44106
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Jobst Vascular Institute
Toledo, Ohio, United States, 43606
United States, Oklahoma
Oklahoma Heart
Oklahoma City, Oklahoma, United States, 73120
United States, South Carolina
Greenville Hospital System
Greenville, South Carolina, United States, 29615
United States, Texas
Cardiothoracic & Vascular Surgeons
Austin, Texas, United States, 78756
Methodist Medical Center
Dallas, Texas, United States, 75208
Dallas VA Medical Center
Dallas, Texas, United States, 75216
United States, Virginia
Sentara Vascular Specialists
Norfolk, Virginia, United States, 23507
Spain
Hospital Virgen de la Salud
Toledo, Spain, 45004
Sponsors and Collaborators
Silk Road Medical
Investigators
Principal Investigator: Christopher Kwolek, MD Massachusetts General Hospital
Principal Investigator: Richard Cambria, MD Massachusetts General Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Silk Road Medical
ClinicalTrials.gov Identifier: NCT01685567     History of Changes
Other Study ID Numbers: SRM-2012-02
Study First Received: September 10, 2012
Results First Received: December 20, 2016
Last Updated: June 12, 2017

Keywords provided by Silk Road Medical:
carotid artery disease
reverse flow

Additional relevant MeSH terms:
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 21, 2017