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Active, Not Recruiting

NCT Number: NCT03957382

Evaluation of Safety and Efficacy of the Accero® (Heal) Stent for Intracranial Aneurysm Treatment

This study is intended to show that the application of the Accero® (heal) stent is safe within the given indication.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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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

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Free and Hanseatic City of Hamburg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Any patient treated with ACCERO® (heal) Stent according to IFU and has signed the informed consent

Exclusion criteria

  • Patient is participating in another clinical trial

Treatment and study plan

Accero® (heal) Stent

Device

The Accero® (heal) Stent will only be used in line with the Instructions For Use (IFU). Patients participating in this PMCF (Post- Market Clinical Follow-up) will not be exposed to any additional risk. There are no additional treatments or investigations other than done in the clinical routine.

Primary outcomes

  1. Raymond Roy Classification

    Time frame: 6 months after treatment

    Assessment of Raymond Roy Classification

  2. Raymond Roy Classification

    Time frame: 12 months after treatment

    Assessment of Raymond Roy Classification

  3. Raymond Roy Classification

    Time frame: 24 months after treatment

    Assessment of Raymond Roy Classification

  4. Raymond Roy Classification

    Time frame: 36 months after treatment

    Assessment of Raymond Roy Classification

Secondary outcomes

  1. modified Rankin Scale (mRS)

    Time frame: 6 months after treatment

    Assessment of modified Rankin Scale

    Modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities.

    The scale runs from 0-6:

    0 - No symptoms.

    • - No significant disability. Able to carry out all usual activities, despite some symptoms.
    • - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    • - Moderate disability. Requires some help, but able to walk unassisted.
    • - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    • - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
    • - Dead.

  2. modified Rankin Scale (mRS)

    Time frame: 12 months after treatment

    Assessment of modified Rankin Scale

    Modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities.

    The scale runs from 0-6:

    0 - No symptoms.

    • - No significant disability. Able to carry out all usual activities, despite some symptoms.
    • - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    • - Moderate disability. Requires some help, but able to walk unassisted.
    • - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    • - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
    • - Dead.

  3. modified Rankin Scale (mRS)

    Time frame: 24 months after treatment

    Assessment of modified Rankin Scale

    Modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities.

    The scale runs from 0-6:

    0 - No symptoms.

    • - No significant disability. Able to carry out all usual activities, despite some symptoms.
    • - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    • - Moderate disability. Requires some help, but able to walk unassisted.
    • - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    • - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
    • - Dead.

  4. modified Rankin Scale (mRS)

    Time frame: 36 months after treatment

    Assessment of modified Rankin Scale

    Modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities.

    The scale runs from 0-6:

    0 - No symptoms.

    • - No significant disability. Able to carry out all usual activities, despite some symptoms.
    • - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    • - Moderate disability. Requires some help, but able to walk unassisted.
    • - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    • - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
    • - Dead.

Sponsors and collaborators

Lead sponsor

Acandis GmbH

Industry

Registry information

Important dates

Study start
2019
Primary completion
2029
Study completion
2029
First posted
May 21, 2019
Registry last updated
Nov 21, 2025

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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