Neuroform Stent System- An FDA approved device under Humanitarian Device Exemption (HDE) for use in Patients with a Wide Neck, Intracranial Aneurysm

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Jacksonville, Florida: 07-003234
    Sponsor Protocol Number: 07-003234

About this study

The purpose of this study is to track the use and potential complications of Neuroform Stent for treating intracranial aneurysms

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria: 

  • Patients harboring a wide neck aneurysm as defined as greater than 4 mm or dome  neck ratio greater to equal to 1:2
  • No contraindication to the use of anti-platelet agents
  • No nickel allergy                 

Exclusion Criteria: 

  • Contraindication for anti-platelet therapy 
  • Nickel allergy

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

David Miller, M.D.

Contact us for the latest status

Contact information:

Cristin Williams

(904)953-8544

Williams.Cristin@mayo.edu

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CLS-20313147

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