A Study of Computer Simulation of Endovascular Repair of Cerebral Aneurysms Aneurysms

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
    • Scottsdale/Phoenix, Arizona: 16-004923
    • Jacksonville, Florida: 16-004923
    • Rochester, Minnesota: 16-004923
    Sponsor Protocol Number: 16-004923

About this study

This study will look at how a new investigational software program, called the Endovantage Interventional Suite (EVIS), can help your doctor better plan surgeries like yours through computer simulation. The software allows your doctor to see how the chosen medical device(s) will perform when it is placed in the blood vessel in your brain. We hope to determine if the computer simulation is realistic and indeed accurately shows your doctor exactly what happened at the time of surgery. If the computer simulation is an accurate reflection of the actual surgery, then the software could help your doctor take better care of future patients with brain aneurysms through improved planning before surgery is performed.

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 who are undergoing standard clinical work up for planned endovascular repair of their intracranial aneurysm with the Pipeline embolization device (a flow diverter

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

David Kallmes, M.D.

Open for enrollment

Contact information:

Marilyn Wood CCRP

(480)342-3484

Wood.Becky@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

David Kallmes, M.D.

Open for enrollment

Contact information:

Cristin Williams

(904)953-8544

Williams.Cristin@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

David Kallmes, M.D.

Open for enrollment

Contact information:

Cindy Fitting CCRP

(507)538-3928

Fitting.Cindy@mayo.edu

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CLS-20304708

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