Status:
COMPLETED
Success in Comaneci-assist Coils Embolization Surveillance Study (SUCCESS)
Lead Sponsor:
Rapid Medical
Conditions:
Intracranial Aneurysm
Eligibility:
All Genders
18-85 years
Brief 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 wi...
Eligibility Criteria
Inclusion
- Patient has a documented intracranial ruptured or unruptured aneurysm, suitable for embolization by coils.
- Patient is considered for treatment with coil embolization assisted by the Comaneci Device for wide-necked intracranial aneurysms with neck width ≤ 10 mm. A wide-necked intracranial aneurysm is defined by the neck width as ≥ 4 mm or a dome-to-neck ratio \< 2.
- A signed informed consent by the patient or legally authorized representative
Exclusion
- 1\. Patient with known hypersensitivity to nickel-titanium
Key Trial Info
Start Date :
November 24 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 7 2024
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04518670
Start Date
November 24 2020
End Date
July 7 2024
Last Update
November 14 2024
Active Locations (8)
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1
USA Health University Hospital
Mobile, Alabama, United States, 36617
2
Carondelet St. Joseph's Hospital (Tenet)
Tucson, Arizona, United States, 85711
3
Santa Barbara Cottage
Santa Barbara, California, United States, 93105
4
Los Robles
Thousand Oaks, California, United States, 91360