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

Silk Road Medical24 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Internal Carotid Artery Stenosis

Interventions

MICHI(TM) NPS+fDEVICE

Transcarotid delivery system for carotid stents with flow reversal

transcarotid stentingPROCEDURE

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (6)

University Hospital

Ghent, Belgium

Augusta Krankenhaus

Düsseldorf, Germany

University Hospital Son Espases

Palma, Mallorca, Spain

Hospital Vall d'Hebron

Barcelona, Spain

Outcomes

Primary Outcomes

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

Time frame: During MICHI(TM) NPS+f procedure

Secondary Outcomes

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

Time frame: 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.

Time frame: During MICHI(TM) NPS+f procedure

Data from ClinicalTrials.gov

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