N/A
Completed N=90
Success in Comaneci-assist Coils Embolization Surveillance Study (SUCCESS)
Source: ClinicalTrials.gov NCT04518670 ↗Enrolled (actual)
90
Serious AEs
41.1%
Results posted
Jan 2026
Primary outcomePrimary: Periprocedural Events — 79 Events
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Periprocedural Events |
79 | — |
| PRIMARY Adverse Events |
150 | — |
| PRIMARY Functional Status |
41; 21; 9; 5; 4; 6 | — |
| PRIMARY Number of Participants With Successful Intracranial Aneurysm Occlusion |
77 | — |
| PRIMARY Number of Participants With Successful Intracranial Aneurysm (IA) Occlusion |
70 | — |
| PRIMARY Number of Participants With Good Clinical Outcome |
57 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- Patient with known hypersensitivity to nickel-titanium
Data sourced from ClinicalTrials.gov (NCT04518670). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.