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

Completed

• Conditions: Internal Carotid Artery Stenosis
• Interventions: Device: MICHI(TM) NPS+f; Procedure: transcarotid stenting

• Registration Number: NCT01877174
• Lead Sponsor: Silk Road Medical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-27
• Study First Submitted QC: 2013-06-10
• Study First Posted: 2013-06-13
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-02
• Last Update Posted: 2014-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MICHI(TM) NPS+f	transcarotid stenting	Patients routinely treated with the CE marked MICHI(TM) NPS+f System
MICHI(TM) NPS+f	MICHI(TM) NPS+f	Patients routinely treated with the CE marked MICHI(TM) NPS+f System

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (6)

University Hospital; 🇧🇪 Gent, Belgium

Augusta Krankenhaus; 🇩🇪 Duesseldorf, Germany

University Hospital Son Espases; 🇪🇸 Palma, Mallorca, Spain

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Medico Quirurgic; 🇪🇸 Jaen, Spain

Complejo Hospitalario de Toledo; 🇪🇸 Toledo, Spain