Success in Comaneci-assist Coils Embolization Surveillance Study (SUCCESS)
NCT ID: NCT04518670
Last Updated: 2026-01-21
Study Results
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View full resultsBasic Information
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COMPLETED
90 participants
OBSERVATIONAL
2020-11-24
2024-07-07
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Comaneci Embolization Assist Device
assist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm.
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. A signed informed consent by the patient or legally authorized representative
Exclusion Criteria
18 Years
85 Years
ALL
No
Sponsors
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Rapid Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Hanel Ricardo, Dr.
Role: PRINCIPAL_INVESTIGATOR
Baptist Neurological Institute
Locations
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USA Health University Hospital
Mobile, Alabama, United States
Carondelet St. Joseph's Hospital (Tenet)
Tucson, Arizona, United States
Santa Barbara Cottage
Santa Barbara, California, United States
Los Robles
Thousand Oaks, California, United States
Baptist Health Research Institute
Jacksonville, Florida, United States
St. Mary's Medical Ctr (Tenet)
West Palm Beach, Florida, United States
University of Buffalo
Buffalo, New York, United States
Texas Stroke Institute (Sarah Cannon TN)
Dallas, Texas, United States
Countries
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References
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Davies JM, Taqi MA, Coon AL, Lin LM, Bohnstedt B, Mascitelli J, Levy EI, Siddiqui A, Birnbaum L, Rodriguez P, Noufal M, Taussky P, Kilburg C, Gooch MR, Puri AS, Diaz O, Fifi JT, Majidi S, Yoo AJ, Soomro J, Bhuva P, Taylor RA, Oni-Orisan AO, Chen M, Sauvageau E, Cordina SM, Sugg RM, Singh J, Goren O, Liebeskind DS, Hanel RA. Comaneci-assisted embolization of wide-necked aneurysms: results from the SUCCESS postmarket US study. J Neurointerv Surg. 2025 Nov 19:jnis-2025-024136. doi: 10.1136/jnis-2025-024136. Online ahead of print.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CLN-Co-001
Identifier Type: -
Identifier Source: org_study_id
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