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Sterling Registry

  • Status
    Accepting Candidates
  • Age
    21 Years - 80 Years
  • Sexes
    All
  • Healthy Volunteers
    No

Objective

A post-market registry evaluating ruptured/unruptured aneurysms treated with MICRUSFRAME and GALAXY coils

Description

A registry to collect real world data on the use of Cerenovus coils. The study will be a post-market registry evaluating ruptured/unruptured aneurysms treated with MICRUSFRAME and GALAXY coils

Details

Full study title A Prospective, Multi-Center, Single Arm Study to Obtain Real World Clinical Data and Characterize the Acute and Long-Term Performance of the MICRUSFRAME and GALAX Coils Including the PulseRider Aneurysm Neck Reconstruction Device for the Treatment of Intracranial Aneurysms
Protocol number OCR19030
ClinicalTrials.gov ID NCT03642639
Phase N/A

Eligibility

Inclusion Criteria:

  1. Patient is between 21 and 80 years of age

  2. Patient has an intracranial saccular aneurysm, ruptured or unruptured, suitable for embolization with coils

  3. Patient is able and willing to comply with protocol and follow-up requirements

Exclusion Criteria:

  1. Pre-planned staged procedure on unruptured aneurysm

  2. More than one aneurysm requiring treatment during the course of study

  3. Fusiform aneurysm

Lead researcher

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

    Matthew Koch
  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.