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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Internal Carotid Artery Stenosis

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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MICHI(TM) NPS+f

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

MICHI(TM) NPS+f

Intervention Type DEVICE

Transcarotid delivery system for carotid stents with flow reversal

transcarotid stenting

Intervention Type PROCEDURE

Interventions

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MICHI(TM) NPS+f

Transcarotid delivery system for carotid stents with flow reversal

Intervention Type DEVICE

transcarotid stenting

Intervention Type PROCEDURE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No