CompletedNo phase
Success in Comaneci-assist Coils Embolization Surveillance Study (SUCCESS)
Key facts
- Who runs it
- Rapid Medical
- Where
- Buffalo, Dallas, Jacksonville, Mobile, Santa Barbara, Thousand Oaks, Tucson, and West Palm Beach, United StatesSee the 8 sites
- Trial code
- Status
- Completed
- People taking part
- 90 people enrolled
- Started
- 24 Nov 2020
- Ended
- 7 Jul 2024
- Type of study
- Observational
- Treatments tested
- Comaneci Embolization Assist Device
- Record updated
- 21 January 2026
Who can take part
- Age
- 18 years to 85 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- Patient with known hypersensitivity to nickel-titanium
Where in United States
- University of BuffaloBuffalo, United StatesNo longer taking part
- Texas Stroke Institute (Sarah Cannon TN)Dallas, United StatesNo longer taking part
- Baptist Health Research InstituteJacksonville, United StatesNo longer taking part
- USA Health University HospitalMobile, United StatesNo longer taking part
- Santa Barbara CottageSanta Barbara, United StatesNo longer taking part
- Los RoblesThousand Oaks, United StatesNo longer taking part
- Carondelet St. Joseph's Hospital (Tenet)Tucson, United StatesNo longer taking part
- St. Mary's Medical Ctr (Tenet)West Palm Beach, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
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The objective of the Postmarket Surveillance Plan is to assess safety and performance as used in postmarket clinical practice in the U.S.
Treatments tested
- Comaneci Embolization Assist Device
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Success in Comaneci-assist Coils Embolization Surveillance Study
- Record updated
- 21 January 2026