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

September 2, 2014 updated by: Silk Road Medical
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gent, Belgium, 9000
        • University Hospital
  • Germany
      • Duesseldorf, Germany, 40472
        • Augusta Krankenhaus
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
      • Jaen, Spain, 23007
        • Hospital Medico Quirurgic
      • Toledo, Spain, 45004
        • Complejo Hospitalario de Toledo
    • Mallorca
      • Palma, Mallorca, Spain, 07120
        • University Hospital Son Espases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who are booked for a routine stenting of the Internal Carotid Artery (bifurcation may be involved) using the MICHI(TM) NPS+f System, at vascular surgery departments or interventional radiology departments

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MICHI(TM) NPS+f
Patients routinely treated with the CE marked MICHI(TM) NPS+f System
Device: MICHI(TM) NPS+f
Transcarotid delivery system for carotid stents with flow reversal
Procedure: transcarotid stenting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During MICHI(TM) NPS+f procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During MICHI(TM) NPS+f procedure
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.
During MICHI(TM) NPS+f procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Silk Road Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

May 27, 2013

First Submitted That Met QC Criteria

June 10, 2013

First Posted (Estimate)

June 13, 2013

Study Record Updates

Last Update Posted (Estimate)

September 3, 2014

Last Update Submitted That Met QC Criteria

September 2, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRM-2013-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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