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NITE 1

Feasibility Study of the treatment of Acute Ischemic Stroke using the NOVIS Transcarotid Neuroprotection System In Transcarotid Embolectomy

  • Clinical Trial Information

    Trial Contact: Carlo, Charlene S; Monserrate, Francheska

    Trial Phone: 321.841.1324 ; 321-841-4717

  • IRB No: 21.133.08

    Protocol Abbrev: NITE 1

    Principal Investigator: Marshall Chandler Cress, MD

    Phase: Device: Category B

    Age Group: Adult

    Secondary Protocol No: SRM-2019-01

    Treatment: The mechanical thrombectomy procedure will be completed by using the NOVIS Transcarotid Neuroprotection System. This procedure will be completed through an incision in your neck where your carotid arteries are located.

    Therapies Involved: Surgery

    ClinicalTrials.gov ID: NCT04881162

  • Objective

    To establish the feasibility and safety of the NOVIS Transcarotid Neuroprotection System when used for the transcarotid intervention of patients that have a failed transfemoral endovascular therapy in the case of anterior circulation strokes due to large vessel embolic occlusions.

  • Key Eligibility

    Patients with acute ischemic anterior circulation stroke due to large vessel embolic occlusion who are candidates for endovascular therapy and in whom transfemoral therapy failed.