Feasibility Study of the Treatment of Acute Ischemic Stroke Using the NOVIS Transcarotid Neuroprotection System

Study Overview
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Brief Summary
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Study Objective is 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.

Detailed Description
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This is a prospective, multi-center, single arm feasibility study for the endovascular treatment of patients with acute ischemic anterior circulation strokes due to large vessel embolic occlusions using the transcarotid approach with flow reversal. Patients enrolled into the NITE 1 Study will have failed transfemoral therapy and will be followed immediately from post-op to 90 days.

Official Title
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Feasibility Study of the Treatment of Acute Ischemic Stroke Using the NOVIS Transcarotid Neuroprotection System In Transcarotid Embolectomy

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Device: NOVIS Transcarotid Neuroprotection System (NPS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Summary: 1. Patients presenting with acute ischemic stroke of the anterior circulation with large vessel occlusions who are eligible for revascularization using endovascular therapies (stentrievers and/or aspiration devices) 2. Occlusion of the intracranial ICA, MCA M1, proximal MCA M2, single-vessel MCA M2, dominant MCA M2, or co-dominant MCA M2 segments 3. Patient has failed transfemoral therapy (see Appendix 4 for definition), and at least 15 minutes have elapsed from groin puncture Exclusion Criteria Summary: 1. Significant disease of the ipsilateral common carotid artery on routine CTA 2. Presence of a cervical ICA loop or other high-risk anatomical features of the ICA on routine CTA, that may preclude the use of the NOVIS NPS 3. Any active or recent hemorrhage within the past 30 days 4. Embolectomy contraindications a. Pre-stroke mRS ≥2 b. NIHSS ≤ 5 c. ASPECTS ≤ 5 5. IV tPA has been or is being administered 6. Last known well > 24 hours ago

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NOVIS Transcarotid Neuroprotection System (NPS)<br>Patients that have failed transfemoral endovascular therapy in the case of anterior circulation strokes due to large vessel embolic occlusions will enrolled in the study and treated using the NOVIS Transcarotid NPS. | Device: NOVIS Transcarotid Neuroprotection System (NPS)<br>* The NOVIS Transcarotid Neuroprotection System (NPS) is intended to provide transcarotid vascular access and embolic protection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device-related Serious Adverse Events | Vascular complications including dissection, pseudoaneurysm, hematoma, arteriovenous fistula, thrombus formation, embolization and any vascular complication that may be attributed to the device AND requires surgical repair, surgical wound revision, transfusion, etc. | procedure to 90 days | 
| Other Serious Adverse Events | Permanent cranial nerve injury, new symptomatic ipsilateral hemorrhage and dissections related to ancillary devices | procedure to 90 days | 
| Functional independence at 90-days | modified Rankin scale score 0-2 (out of a maximum scale of 6. A lower score indicates better outcome, a higher score indicates worse outcome) | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mechanical thrombectomy, stroke treatment, embolic protection, transcarotid