Success in Comaneci-assist Coils Embolization Surveillance Study (SUCCESS)

Study Overview
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Brief Summary
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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.

Official Title
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Success in Comaneci-assist Coils Embolization Surveillance Study

Conditions
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Intracranial Aneurysm

Intervention / Treatment
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* Device: Comaneci Embolization Assist Device


Participation Criteria
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Eligibility Criteria
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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: 1. Patient with known hypersensitivity to nickel-titanium

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Comaneci Embolization Assist Device|assist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periprocedural events | Rates of all adverse events occurring within 24 hours post-procedure and hospital discharge status. | 24 Hours post procedure | 
| Adverse events | All adverse events at discharge and up to 30 days post procedure. | 30 days post procedure | 
| Functional status | Functional status at discharge and 30 days assessed using the modified Rankin Scale (mRS). using the modified Rankin Scale (mRS). This scale runs from 0-6, from no symptoms to death as follows: 0 - No symptoms 1 - No significant disability. Able to carry out all usual activities, despite some symptoms. 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead. | 30 days post procedure | 
| Successful intracranial aneurysm occlusion | Successful intracranial aneurysm occlusion (measured by Raymond Roy classification I or II) at the end of procedure, using digital subtraction angiography (DSA). | end of procedure | 
| Successful intracranial aneurysm (IA) occlusion | Successful intracranial aneurysm (IA) occlusion, that is a stable IA occlusion, measured by Raymond Roy classification I or II taken at 6 months (± 21d) post procedure without the need for re-treatment of the target IA, using DSA. | 6 Months Post procedure | 
| Good clinical outcome | Good clinical outcome- mRS shift @ 6 months (change @ 6 months from pre procedure) and tetrachotomized (0,1, 2, 3-6) mRS analysis | 6 Months Post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rapid Medical, aneurysm, Comaneci, Neurovascular intervention, Brain