Wingspan Stent System with Gateway PTA Balloon Catheter for use in Improving Cerebral Artery Lumen Diameter in Patients with Intracranial Artherosclerotic Disease

Overview

  • Study type

    Interventional
  • 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: 07-003231
    Sponsor Protocol Number: 07-003231

About this study

The risk of ischemic stroke in patients with Intracranial Atherosclerotic Disease (ICAD) ranges from 7 to 24 %.  Developed specifically for the treatment of ICAD, the Wingspan Stent System and Gateway PTA Balloon Catheter delivers new options for ischemic stroke.

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 with intracranial atherosclerotic disease 
    • Refractory to medical therapy 
    • In intracranial vessels with greater than or equal to 50% stenosis that are accessible to the system

Exclusion Criteria:

  • Intracranial artery stenting is generally contraindicated in the following patient types:
    • Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated
    • Lesions that are highly calcified or otherwise could prevent access or appropriate expansion of the stent

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-20312404

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