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

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

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

Conditions
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Intracranial Aneurysm

Intervention / Treatment
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* Device: Accero® (heal) Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients treated with Accero® (heal) Stent according to IFU Exclusion Criteria: mRS > 2 Hunt and Hess >3 (in patients with subarachnoid hemorrhage-SAH)
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: Accero® (heal) Stent|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Raymond Roy Classification | Assessment of Raymond Roy Classification | 6 months after treatment | 
| Raymond Roy Classification | Assessment of Raymond Roy Classification | 12 months after treatment | 
| Raymond Roy Classification | Assessment of Raymond Roy Classification | 24 months after treatment | 
| Raymond Roy Classification | Assessment of Raymond Roy Classification | 36 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Rankin Scale (mRS) | 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. | 6 months after treatment | 
| modified Rankin Scale (mRS) | 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. | 12 months after treatment | 
| modified Rankin Scale (mRS) | 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. | 24 months after treatment | 
| modified Rankin Scale (mRS) | 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. | 36 months after treatment |