Ultra Coils From Start to Finish for the Endovascular Repair of Small

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02657772
Study type	Observational [Patient Registry]
Source	University of Maryland, Baltimore
Contact
Status	Completed
Phase
Start date	November 2013
Completion date	March 2021

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Ultra Coils From Start to Finish for the Endovascular Repair of Small Intracranial Aneurysms — ULTRA

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms