Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil

Overview

  • Study type

    Interventional
  • Study phase

    IV
  • 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
    • Jacksonville, Florida: 16-006704
    NCT ID: NCT02729740
    Sponsor Protocol Number: CLP 10023.B

About this study

The primary objective of this study is to gather post market data on the Penumbra SMART Coil™ System in the treatment of intracranial aneurysms and other malformations.

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 enrolled in this study must sign Informed Consent and be treated according to the cleared indications for the Smart, PC 400, and POD, which include the embolization of:

  • Intracranial aneurysms
  • Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae

Exclusion Criteria:

  • Life expectancy less than one year
  • Smart, PC 400, or POD account for less than 75% of total number of coils opened
  • Participation in another clinical investigation that could confound the evaluation of the study device

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Rabih Tawk, M.D.

Open for enrollment

Contact information:

Cristin Williams

(904)953-8544

Williams.Cristin@mayo.edu

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CLS-20317436

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