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.

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Key information

Conditions

Internal Carotid Artery Stenosis Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital, Ghent, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MICHI(TM) NPS+f

Device

Transcarotid delivery system for carotid stents with flow reversal

transcarotid stenting

Procedure

Primary outcomes

Percentage of patients with debris captured in the MICHI(TM) inline filter

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

The percentage of patients with any debris captured in the MICHI(TM) inline filter will be calculated

Secondary outcomes

Volume of debris captured in the MICHI(TM) inline filter

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Silk Road Medical

Industry

Registry information

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Jun 13, 2013
Registry last updated: Sep 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed