MedTrace Logo

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

NCT01877174 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2014-09-03

No results posted yet for this study

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.

Conditions

  • Internal Carotid Artery Stenosis

Interventions

DEVICE

MICHI(TM) NPS+f

Transcarotid delivery system for carotid stents with flow reversal

PROCEDURE

transcarotid stenting

Sponsors & Collaborators

  • Silk Road Medical

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Belgium
  • Germany
  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01877174 on ClinicalTrials.gov