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Trial record 1 of 1 for:    NCT03957382
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Evaluation of Safety and Efficacy of the Accero® Stent for Intracranial Aneurysm Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03957382
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
Acandis GmbH

Brief Summary:
This study is intended to show that the application of the Accero® stent is safe within the given indication.

Condition or disease Intervention/treatment
Intracranial Aneurysm Device: Accero® Stent

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Safety and Efficacy of the Accero® Stent for Intracranial Aneurysm Treatment
Actual Study Start Date : July 23, 2019
Estimated Primary Completion Date : September 1, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Accero® Stent
    The Accero® 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 Outcome Measures :
  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 Outcome Measures :
  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.

    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.

  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.

    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.

  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.

    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. 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.

    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients treated with Accero® Stent
Criteria

Inclusion Criteria:

All patients treated with Accero® Stent according to IFU

Exclusion Criteria:

  • mRS > 2
  • Hunt and Hess >3 (in patients with subarachnoid hemorrhage-SAH)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03957382


Contacts
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Contact: Acandis GmbH +49 7231 155 00 0 info@acandis.com

Locations
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Germany
Vivantes - Klinikum Neukölln Institut für klinische und interventionelle Neuroradiologie Recruiting
Berlin, Germany, 12351
Contact: Dr. Alexander Bock         
Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Universitätsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Dr. Maxim Bester         
Sponsors and Collaborators
Acandis GmbH
Investigators
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Principal Investigator: Maxim Bester, PD. Dr. Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Universitätsklinikum Hamburg-Eppendorf
Principal Investigator: Oliver Beuing, Dr. Institut für Neuroradiologie, Universitätsklinikum Magdeburg
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Responsible Party: Acandis GmbH
ClinicalTrials.gov Identifier: NCT03957382    
Other Study ID Numbers: 1041-1
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases