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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01877174

Enrollment

Registered

2013-06-13

Start date

2013-05-31

Completion date

2013-10-31

Last updated

2014-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Internal Carotid Artery Stenosis

Keywords

Internal Carotid Stenosis, Reverse Flow, Carotid stenting, MICHI(TM) NPS+f

Brief summary

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.

Interventions

DEVICEMICHI(TM) NPS+f

Transcarotid delivery system for carotid stents with flow reversal

PROCEDUREtranscarotid stenting

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion 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

Design outcomes

Primary

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

Secondary

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

Countries

Belgium, Germany, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026