Clinical Trial: Ultra Coils From Start to Finish for the Endovascular Repair of Small Intracranial Aneurysms

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Ultra Coils From Start to Finish for the Endovascular Repair of Small Intracranial Aneurysms

Brief 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 Summary:

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 captur
Sponsor: University of Maryland

Current Primary Outcome: Target Aneurysm Recurrence (TAR) [ Time Frame: 9-18 months ]

Target Aneurysm Recurrence (TAR) - defined as clinically relevant recurrence resulting in: target aneurysm re-intervention, rupture/re-rupture, and/or death from unknown cause as assessed at 9-18 months post procedure.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Residual Aneurysm assessment using modified Raymond Scale [ Time Frame: 9-18 months ]
    Residual Aneurysm assessment using modified Raymond Scale (complete occlusion, minimal residual, residual aneurysm)
  • Modified Rankin Scale [ Time Frame: 9-18 months ]
    Assess the disability or degree of dependence of participants with Modified Rankin Scale score </=2 to determine good clinical outcomes at 9-18 months. It is compared with baseline values.
  • Technical procedural success [ Time Frame: Procedure ]
    Technical procedural success defined as the successful delivery and deployment of Ultra® coils in the target aneurysm


Original Secondary Outcome: Same as current

Information By: University of Maryland

Dates:
Date Received: January 14, 2016
Date Started: November 2013
Date Completion:
Last Updated: January 15, 2016
Last Verified: December 2015