MICHI™ Neuroprotection System (NPS+f) Filter Debris Analysis Study (The F-1 Study)

Study Overview
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Brief Summary
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This study will be conducted in up to 10 hospitals in Europe, up to 75 patients will be enrolled. The purpose of the study is to evaluate any debris that may be captured in the inline filter of the MICHI(TM) Neuroprotection System with Filter (NPS+f) during its use in a transcarotid stenting procedure. The MICHI NPS+f is an embolic protection device that uses reverse flow to protect the brain during stenting of the Internal Carotid Artery. It is CE marked and is used in routine practice for the purpose of this study.

Official Title
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MICHI™ Neuroprotection System (NPS+f) Filter Debris Analysis Study (The F-1 Study)

Conditions
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Internal Carotid Artery Stenosis

Intervention / Treatment
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* Device: MICHI(TM) NPS+f
* Procedure: transcarotid stenting


Participation Criteria
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Eligibility Criteria
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Inclusion and exclusion criteria per CE marked Instructions For Use Inclusion Criteria: Adequate central venous access Common carotid artery reference diameter of at least 6 mm Carotid bifurcation is a minimum of 5 cm above the clavicle as measured by duplex Doppler ultrasound (DUS) or computerized axial tomography (CT) angiography or magnetic resonance (MR) angiography Exclusion Criteria: Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated Patients with unresolved bleeding disorders Patients with severe disease of the ipsilateral common carotid artery
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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MICHI(TM) NPS+f<br>Patients routinely treated with the CE marked MICHI(TM) NPS+f System | Device: MICHI(TM) NPS+f<br>* Transcarotid delivery system for carotid stents with flow reversal<br>Procedure: transcarotid stenting<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with debris captured in the MICHI(TM) inline filter | The percentage of patients with any debris captured in the MICHI(TM) inline filter will be calculated | During MICHI(TM) NPS+f procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of debris captured in the MICHI(TM) inline filter | For all patients, where debris is captured in the MICHI(TM) inline filter, the volume of debris will be measured | During MICHI(TM) NPS+f procedure | 
| Histological analysis of debris captured in the MICHI(TM) inline filter | For all patients, where debris is captured in the MICHI(TM) inline filter, the type of plaque will be determined. | During MICHI(TM) NPS+f procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Internal Carotid Stenosis, Reverse Flow, Carotid stenting, MICHI(TM) NPS+f