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The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Study

NCT03985774 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 31

Last updated 2021-04-19

No results posted yet for this study

Summary

The goal of this study is to evaluate the incidence of post procedure DW-MRI lesions (relative to baseline) and debris captured in the ENROUTE Transcarotid NPS inline filter during a transcarotid stenting procedure.

Conditions

  • Carotid Stenosis
  • Carotid Artery Diseases
  • Carotid Atherosclerosis
  • Carotid Artery Plaque

Interventions

PROCEDURE

Transcarotid revascularization

The ENROUTE Transcarotid Neuroprotection System (NPS) has received CE Mark and is commercially available in the European Union. The ENROUTE Transcarotid NPS may be used in conjunction with carotid artery stent approved for revascularization in patients with carotid disease The ENROUTE Transcarotid Neuroprotection System is intended to provide transcarotid vascular access, introduction of diagnostic agents and therapeutic devices, and embolic protection during carotid artery angioplasty and stenting procedures for patients diagnosed with carotid artery stenosis

Sponsors & Collaborators

  • Complejo Hospitalario Toledo

    collaborator OTHER

  • University Ghent

    collaborator OTHER

  • Technical University of Munich

    collaborator OTHER

  • Silk Road Medical

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-26
Primary Completion
2021-03-25
Completion
2021-03-25
FDA Device
Yes

Countries

  • Belgium
  • Germany
  • Spain

Study Locations

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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 NCT03985774 on ClinicalTrials.gov