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Heart and Vascular

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SLUHN 2016-56

Registry of Transcarotid Artery Revascularization in Patients with Significant Carotid Artery Disease: The Roadster 2 Registry

  • Physician & Study Coordinator
  • Synopsis
  • Inclusion Criteria
  • Exclusion Criteria
  • Study Coordinator

    Leah Bryant, LPN
    484-526-7825

    leah.bryant@sluhn.org 
  • Synopsis: This registry is intended to collect data of patients receiving an FDA-approved ENROUTE Transcarotid System for the treatment of carotid artery disease. The safety and effectiveness of the ENROUTE Neuroprotection System and the ENROUTE Stent has already been proven to the FDA. The purpose of this study is to evaluate a patient’s clinical outcome when using the neck as the primary access point and using the ENROUTE Stent shorter deliver system.

    The information collected in this study will be used to establish real world usage of the ENROUTE Transcarotid Neuroprotection System for use in patients who are symptomatic and asymptomatic and at high risk for surgery. It may also be used in reports of the study or for scientific presentations. The sponsor may also use the information from this study for future medical research, which may be performed by the sponsor together with other companies or researchers.

  • 1. Patient must meet one of the following criteria regarding neurological symptom status and degree of stenosis:

    Symptomatic: Stenosis must be >50% as determined by an angiogram and the patient has a history of stroke (minor or non-disabling), TIA and/or amaurosis fugax within 180 days of the procedure procedure ipsilateral to the carotid artery to be stented.

    OR

    Asymptomatic: Stenosis must be >80% as determined by angiogram without any neurological symptoms within the prior 180 days.

    2. Target vessel must meet all requirements for ENROUTE Transcarotid Neuroprotection System and ENROUTE Stent System (refer to IFU for 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 >18 years of age.
    5. 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 of the respective clinical site prior to the procedure. This will be obtained prior to participation in the study.
    6. Patient is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.
    7. Patient meets at least one of the surgical high-risk criteria listed below.

    Anatomic High Risk Inclusion Criteria:

    A. Contralateral carotid artery occlusion
    B. Tandem stenoses >70%
    C. High cervical carotid artery stenosis
    D. Restenosis after carotid endarterectomy
    E. Bilateral carotid artery stenosis requiring treatment within 30 days after index treatment.
    F. Hostile Necks which the Investigator deems safe for transcarotid access including but not limited to:
    I. Prior neck irradiation
    II. Radical neck dissection
    III. Cervical spine immobility

    Clinical High Risk Inclusion Criteria:

    G. Patient is > 75 years of age
    H. Patient has > 2-vessel coronary artery disease and history of angina of any severity
    I. Patient has a history of angina
    Canadian Cardiovascular Society (CCS) angina class 3 or 4
    or
    unstable angina
    J. Patient has congestive heart failure (CHF) - New York Heart Association (NYHA)
    Functional Class III or IV
    K. Patient has known severe left ventricular dysfunction
    LVEF <30%.
    L. Patient has had a myocardial infarction > 72 hours and < 6 weeks prior to procedure.
    M. Patient has severe pulmonary disease (COPD) with either:
    FEV1 <50% predicted or
    chronic oxygen therapy or
    resting PO2 of <60 mmHg (room air)
    N. Patient has permanent contralateral cranial nerve injury
    O. Patient has chronic renal insufficiency (serum creatinine > 2.5 mg/dL).
    P. Patient must have a life expectancy ≥ 3 years at the time of the index procedure without contingencies related to other medical, surgical or endovascular intervention.

    NOTE: Anatomy that renders transfemoral CAS hazardous (CREST 2 exclusion criteria) can also be included in the ROADSTER 2 Registry.

    I. TypeII, III, or Bovine arch
    II. Arch atheroma or calcification
    III. Atheroma of the great vessel origins
    IV. Tortuous distal ICA
    V. Tortuous or occluded iliofemoral segments
    VI. Occluded aortoiliac segments 

  • 1. Patient has an alternative source of cerebral embolus, including but not limited to:

    a. Patient has chronic atrial fibrillation.

    b. Patient has had any episode of paroxysmal atrial fibrillation within the past 6 months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation.

    c. 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).

    d. Recently (<60 days) implanted heart valve (either surgically or endovascularly), which is a known source of emboli as confirmed on echocardiogram.

    e. Abnormal angiographic findings: ipsilateral intracranial or extracranial arterial stenosis (as determined by angiography of CTA/MRA less than/or equal to 6 months prior to index procedure) 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. 

    2. Patient has a history of spontaneous intracranial hemorrhage within the past 12 months, or 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.

    3. Patient had hemorrhagic transformation of an ischemic stroke within the past 60 days.

    4. Patient with a history of major stroke attributable to either carotid artery (CVA or retinal embolus) with major neurological deficit (NIHSS greater than/or equal to 5 OR mRS greater than/or equal to 3) likely to confound study endpoints within 1 month of index procedure.

    5. Patient has an intracranial tumor.

    6. Patient has an evolving stroke.

    7. 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, including but not limited to: moderate to severe dementia, 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, or intracranial hemorrhage.

    8. Patient has had a TIA or amaurosis fugax within 48 hrs prior to the procedure.

    9. Patient has an isolated hemisphere.

    10. Patient had or will have CABG, endovascular stent procedure, valve intervention or vascular surgery within 30 days before or after the intervention.

    11. Myocardial Infarction within 72 hours prior to the intervention.

    12. Presence of a previous placed intravascular stent in target vessel or ipsilateral CCA or significant CCA inflow lesion.

    13. Occlusion or [Thrombolysis in Myocardial Infarction Trial (TIMI 0)] "string sign" > 1cm of the ipsilateral common or internal carotid artery.

    14. 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)

    15. Ostium of Common Carotid Artery (CCA) requires revascularization

    16. Patient has an open stoma in the neck.

    17. Female patients who are pregnant or may become pregnant. 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, statin or contrast media (that can't be pre medicated). Patients must be able to tolerate statins and a combination of ASA and ticlopidine or ASA and clopidogrel.

    18. Patient must have a life expectancy <3 years without contingencies related to other medical, surgical, or interventional procedures as per the Wallaert Score and patients with primary, recurrent, or metastatic malignancy who do not have independent assessment of life expectancy performed by the treating oncologist or an appropriate specialist other than the physician performing TCAR.