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Procedure
Treatment for Brain Aneurysm
N/A
Waitlist Available
Led By Hanel Ricardo, Dr.
Research Sponsored by Rapid Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post procedure
Awards & highlights
Summary
The Comaneci Embolization Assist Device is indicated for use in the neurovasculature as a temporary endovascular device used to assist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm. A wide-necked intracranial aneurysm (IA) defines the neck width as ≥ 4 mm or a dome-to-neck ratio \< 2. The objective of the Postmarket Surveillance Plan is to assess safety and performance as used in postmarket clinical practice in the U.S.
Eligible Conditions
- Brain Aneurysm
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse events
Functional status
Good clinical outcome
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Who is running the clinical trial?
Rapid MedicalLead Sponsor
6 Previous Clinical Trials
1,299 Total Patients Enrolled
Hanel Ricardo, Dr.Principal InvestigatorBaptist Neurological Institute
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