BOB体育

Skip to main content
(352) 733-0111

Citadel

  • Status
    Accepting Candidates
  • Age
    18 Years - 80 Years
  • Sexes
    All
  • Healthy Volunteers
    No
I'm interested
Share this study

Objective

The purpose of this study is to gather safety and effectiveness data on Stryker Neurovascular's Next Generation Target Detachable Coil (hereafter referred to as the Citadel Embolization Device), when used with Target Detachable Coils, in the treatment of wide-neck intracranial aneurysms.

Description

In this study, use of the Citadel Embolization Device will be limited to a population of patients with unruptured or ruptured wide-neck aneurysms who meet all study eligibility criteria. The Citadel Embolization Device is intended to endovascularly obstruct or occlude blood flow in intracranial aneurysms.

Details

Full study title The Citadel Embolization Device Study Protocol
Protocol number OCR45822
ClinicalTrials.gov ID NCT04057352
Phase N/A

Eligibility

Inclusion Criteria:

  1. Age is 鈮�18 and 鈮�80 years

  2. Has a single, unruptured or ruptured target intracranial aneurysm that is suitable for endovascular treatment. Definition: For the purposes of this study, a ruptured intracranial aneurysm is defined as one with CT/MRI/LP evidence of subarachnoid hemorrhage attributed to the index aneurysm within the last 60 days.

  3. Aneurysm morphology is saccular

  4. Aneurysm size is between 6-12 mm

  5. Has a wide-neck, saccular aneurysm, either bifurcation or sidewall, with a dome to neck ratio

Lead researcher

  • Nohra Chalouhi, MD
    Neurosurgeon, Spine Surgeon, Neurovascular Surgeon
    Languages: Arabic, French
    Nohra Chalouhi

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

  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.