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.
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.
Study Type
OBSERVATIONAL
Enrollment
100
Christiana Care Health System
Newark, Delaware, United States
WellStar Research Institute
Marietta, Georgia, United States
University of Maryland Baltimore
Baltimore, Maryland, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Target Aneurysm Recurrence (TAR)
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.
Time frame: 9-18 months from baseline/procedure date
Residual Aneurysm assessment using modified Raymond Scale
Residual Aneurysm assessment using modified Raymond Scale (complete occlusion, minimal residual, residual aneurysm)
Time frame: 9-18 months from baseline/procedure date
Modified Rankin Scale
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.
Time frame: Baseline, 1 Day post procedure, 3- 28 days post procedure, 3-9 months, 9-18 months from baseline/procedure date
Technical procedural success
Technical procedural success defined as the successful delivery and deployment of Ultra® coils in the target aneurysm
Time frame: Procedure
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Geisinger medical center
Danville, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States