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

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

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.

Inclusion and exclusion criteria per CE marked Instructions For Use

Inclusion Criteria:

1. Adequate central venous access
2. Common carotid artery reference diameter of at least 6 mm
3. 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:

1. Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated
2. Patients with unresolved bleeding disorders
3. Patients with severe disease of the ipsilateral common carotid artery