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

Silk Road Medical

Status: Completed

Conditions: Internal Carotid Artery Stenosis

Treatments: Procedure: transcarotid stenting; Device: MICHI(TM) NPS+f

Study type: Observational

Funder types: Industry

Identifiers

NCT01877174

SRM-2013-01

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

24 participants in 1 patient group

MICHI(TM) NPS+f

Description:

Patients routinely treated with the CE marked MICHI(TM) NPS+f System

Treatment:

Device: MICHI(TM) NPS+f

Procedure: transcarotid stenting