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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 2013

Interventions

  • Device: MICHI(TM) NPS+f
    • Transcarotid delivery system for carotid stents with flow reversal
  • Procedure: transcarotid stenting

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Silk Road Medical
  • Provider of Information About this Clinical Study
    • Sponsor

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