The MICHI NEUROPROTECTION SYSTEM: Evaluation of Performance in Carotid Artery Stent Procedures (The LOTUS Study) (LOTUS)

This is an interventional treatment trial for Carotid Stenosis Read More

Inclusion Criteria:

• Subject must be > 21 years of age.
• Subject has the ability to understand and cooperate with study procedures and agrees to return for all required follow-up visits, tests, and exams.
• International Normalized Ratio (INR) must be ≤ 1.5 at the time of the procedure (subjects taking warfarin may be included if their dose is tapered prior to the procedure to meet the inclusion criterion. Dose may be returned to a therapeutic level after the procedure).
• The subject must sign a written informed consent prior to the procedure, using a form that is approved by the local medical Ethics Committee (EC).
• The life expectancy of the subject is at least one year.
• The subject has a lesion located in the internal carotid artery (ICA); the carotid bifurcation may be involved.
• The subject must have a minimum distance of 5 cm between the clavicle and bifurcation, as assessed by duplex Doppler ultrasound, computed axial tomographic (CT) angiography or magnetic resonance (MR) angiography.

Exclusion Criteria:

• The subject is participating in another investigational study that would interfere with the conduct or result of this study.
• The subject has dementia or a neurological illness that may confound the neurological evaluation.

• Presence of any one of the following anatomic risk factors:

  • Previous radiation treatment to the neck or radical neck dissection
  • Tracheostomy or tracheal stoma
  • Laryngectomy
  • Contralateral laryngeal nerve palsy
  • Severe tandem lesions
  • Inability to extend the head due to cervical arthritis or other cervical disorders
• Total occlusion of the target vessel.
• There is an existing, previously placed stent in the target artery.
• The subject has a known life-threatening allergy to the contrast media that cannot be treated.
• Subject has history of intolerance or allergic reaction to any of the study medications including aspirin, clopidogrel bisulfate (Plavix®) or ticlopidine (Ticlid®), prasugrel heparin or bivalirudin (Angiomax™). Subjects must be able to tolerate a combination of aspirin and clopidogrel/ticlopidine or prasugrel.
• The subject has a gastrointestinal bleed that would interfere with antiplatelet therapy.
• The subject has known cardiac sources of emboli.
• Subject has Hemoglobin (Hgb) less than 8 gm/dL (unless on dialysis), platelet count < 50,000/mm3, or known heparin associated thrombocytopenia.
• Subject has documented atrial fibrillation in the prior 90 days.
• The subject has a history of bleeding diathesis or coagulopathy including thrombocytopenia or an inability to receive heparin in amounts sufficient to maintain an activated clotting time (ACT) at > 250, or if the subject will refuse blood transfusions.
• The subject has atherosclerotic disease involving the ipsilateral common carotid artery (CCA) that precludes safe placement of the sheath.
• The subject has abnormal angiographic findings other than that of the target lesion that indicate the subject is at risk for a stroke, such as: ipsilateral arterial stenosis greater in severity than the target lesion, cerebral aneurysm, or arteriovenous malformation of the cerebral vasculature.
• There is evidence of a carotid artery dissection prior to the initiation of the procedure.
• There is an angiographically visible thrombus.
• There is any condition that precludes proper angiographic assessment or makes percutaneous arterial access unsafe, e.g. morbid obesity, sustained systolic blood pressure > 180 mm Hg, tortuosity, occlusive disease, vessel anatomy or aortic arch anatomy.
• Occlusion (TIMI 0 flow), or string sign of the ipsilateral common or internal carotid artery.
• There is evidence of bilateral carotid stenosis that would require intervention within 30 days of procedure.
• There is evidence of a major stroke (NIHSS ≥10) within the previous 30 days of the procedure or the patient is considered, by the investigator, to be at high risk for hemorrhagic stroke.
• There is a planned treatment of a non-target lesion within 30 days post procedure.
• There is a history of intracranial hemorrhage within the previous 3 months, including hemorrhagic transformation of an ischemic stroke.
• There is history of an ipsilateral stroke with fluctuating neurologic symptoms within one year prior to the procedure.
• Female subjects who are pregnant (negative pregnancy test is required in women of childbearing potential).
• Subjects, who the Investigator determines, to be at risk of Deep Vein Thrombosis (DVT)