Ultra Coils From Start to Finish for the Endovascular Repair of Small Intracranial Aneurysms
Condition: Intracranial Aneurysms
MeSH terms: Intracranial Aneurysm; Aneurysm
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is to assess the safety and efficacy rates of the treatment of
      small intracranial aneurysms with Stryker Neurovascular's Target® 360 Ultra coils which are a
      type of platinum coils used to occlude aneurysms.
    

Detailed description: 
      This is a Prospective single-arm multi-center Registry which aims to collect data to
      determine the safety and efficacy of one of these marketed coils, namely the Target® 360
      Ultra coils. This is not an intervention or treatment study. Up to 100 subjects at up to 6
      sites will be enrolled.

      Study Procedure

        1. Screening and Informed consent: Patients will undergoing endovascular treatment of
           intracranial aneurysm will be screened using the Eligibility criteria checklist, and
           enrolled using approved Institutional Informed Consent process and approved Informed
           Consent form.

        2. Baseline assessment: This involves standard of care history, medical examinations and
           laboratory assessments prior to coiling procedure.

        3. Coiling procedure

        4. One day post procedure assessment

        5. 3- 28 days post procedure assessment

        6. 3-9 months post procedure assessment

        7. 9-18 months post procedure assessment

      The Site investigator and/or co-investigator or their representative(s) will conduct training
      before initiating the study to develop a common understanding of the clinical protocol, Case
      Report Forms, and study procedures among the investigators and site research staff.
      Regulatory binders with study protocol, training documents, and standard operating guidelines
      will be provided for each study site. The Principal investigator and/or co-investigator shall
      confirm data received is accurate by reviewing with the provider collecting the data. The
      principle investigator and/or co-investigator will approve all data received. Additionally,
      OpenClinica, a web-based data capture service, will receive all Case Report Forms.

      Study Monitoring will be electronic requiring upload of de-identified source documents
      through provided secure channels. However on site visits maybe scheduled in advance with the
      site personnel. Audits may be also be performed for quality assurance.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be between 18 and 80 years of age (inclusive)and have a documented untreated
        intracranial aneurysm, less than or equal to 5 mm, ruptured or unruptured, for which Ultra®
        coils are treatment options, and for which primary coiling treatment is planned to be
        completed during a single procedure (i.e., no "staged" treatment). Preliminary intracranial
        stent placement and/or use of an intracranial endoluminal balloon device as adjunctive
        therapy is allowed.
      
Keywords: Target Ultra coils; small aneurysms