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出境医 / 临床实验 / Evaluation of Safety and Efficacy of the Accero® Stent for Intracranial Aneurysm Treatment

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

Study Description
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

Study Design
Layout table for study information
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
Arms and Interventions
Outcome Measures
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.


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date May 16, 2019
First Posted Date May 21, 2019
Last Update Posted Date August 25, 2020
Actual Study Start Date July 23, 2019
Estimated Primary Completion Date September 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 17, 2019)
  • Raymond Roy Classification [ Time Frame: 6 months after treatment ]
    Assessment of Raymond Roy Classification
  • Raymond Roy Classification [ Time Frame: 12 months after treatment ]
    Assessment of Raymond Roy Classification
  • Raymond Roy Classification [ Time Frame: 24 months after treatment ]
    Assessment of Raymond Roy Classification
  • Raymond Roy Classification [ Time Frame: 36 months after treatment ]
    Assessment of Raymond Roy Classification
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 22, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures
 (submitted: May 17, 2019)
  • modified Rankin Scale (mRS) [ Time Frame: 6 months after treatment ]
    Assessment of modified Rankin Scale
  • modified Rankin Scale (mRS) [ Time Frame: 12 months after treatment ]
    Assessment of modified Rankin Scale
  • modified Rankin Scale (mRS) [ Time Frame: 24 months after treatment ]
    Assessment of modified Rankin Scale
  • modified Rankin Scale (mRS) [ Time Frame: 36 months after treatment ]
    Assessment of modified Rankin Scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Safety and Efficacy of the Accero® Stent for Intracranial Aneurysm Treatment
Official Title Evaluation of Safety and Efficacy of the Accero® Stent for Intracranial Aneurysm Treatment
Brief Summary This study is intended to show that the application of the Accero® stent is safe within the given indication.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients treated with Accero® Stent
Condition Intracranial Aneurysm
Intervention 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 22, 2019) 		130
Original Estimated Enrollment
 (submitted: May 17, 2019) 		200
Estimated Study Completion Date December 31, 2024
Estimated Primary Completion Date September 1, 2024   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Acandis GmbH +49 7231 155 00 0 info@acandis.com
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03957382
Other Study ID Numbers 1041-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Acandis GmbH
Study Sponsor Acandis GmbH
Collaborators Not Provided
Investigators
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
PRS Account Acandis GmbH
Verification Date August 2020

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