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Completed

NCT Number: NCT04518670

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

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.

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Key information

Conditions

Intracranial Aneurysm Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

USA Health University Hospital, Mobile, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comaneci Embolization Assist Device

Device

assist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm.

Primary outcomes

  1. Periprocedural Events

    Time frame: 24 Hours post procedure

    Rates of all adverse events occurring within 24 hours post-procedure and hospital discharge status.

  2. Adverse Events

    Time frame: 30 days post procedure

    All adverse events at discharge and up to 30 days post procedure.

  3. Functional Status

    Time frame: 30 days post procedure

    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.

  4. Number of Participants With Successful Intracranial Aneurysm Occlusion

    Time frame: end of procedure

    Successful intracranial aneurysm occlusion (measured by Raymond Roy classification I or II) at the end of procedure, using digital subtraction angiography (DSA).

  5. Number of Participants With Successful Intracranial Aneurysm (IA) Occlusion

    Time frame: 6 Months Post procedure

    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. Number of Participants With Good Clinical Outcome

    Time frame: 6 Months Post procedure

    Good clinical outcome- mRS shift @ 6 months (change @ 6 months from pre procedure) and tetrachotomized (0,1, 2, 3-6) mRS analysis

Sponsors and collaborators

Lead sponsor

Rapid Medical

Industry

Registry information

Official study title

Success in Comaneci-assist Coils Embolization Surveillance Study

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 19, 2020
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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