Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms

Overview

  • Study type

    Interventional
  • Study phase

    II/III
  • 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.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 14-001982
    NCT ID: NCT01801007
    Sponsor Protocol Number: CL12001

About this study

The purpose of this study is to evaluate the safety and effectiveness of the MicroVention Flow Redirection Intraluminal Device (FRED) system when used in the treatment of wide-necked 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:

  • Subject whose age ≥ 22 and ≤ 75 years
  • Subject has single target aneurysm located in the internal carotid artery
  • Subject fulfills study requirements and his/her legally authorized representative provides a signed informed consent form

Exclusion Criteria:

  • Subject who suffers from an intracranial hemorrhage in the last 30 days
  • Subject who suffers from a subarachnoid hemorrhage in the last 60 days
  • Subject with symptomatic extracranial mass or currently undergoing radiation therapy for tumor of the head and nexk region
  • Subject who is pregnant or breastfeeding
  • Subject has an arteriovenous malformation (AVM)in the area of the target aneurysm

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

David Kallmes, M.D.

Contact us for the latest status

Contact information:

Beth Connelly CCRP

(507)538-0540

Connelly.Beth@mayo.edu

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CLS-20149887

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