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This study is intended to show that the application of the Accero® (heal) stent is safe within the given indication.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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.
|
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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
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All patients treated with Accero® (heal) Stent
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| Name | Affiliation | Role |
|---|---|---|
| Maxim Bester, PD. Dr. | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Universitätsklinikum Hamburg-Eppendorf | Hamburg | Free and Hanseatic City of Hamburg | 20246 | Germany |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D015607 | Stents |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| 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.
| 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.
| 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.
| 36 months after treatment |
| Vivantes - Klinikum Neukölln Institut für klinische und interventionelle Neuroradiologie | Berlin | 12351 | Germany |
| Krankenhaus Ludmillenstift, Abteilung für Radiologie, Neuroradiologie und Nuklearmedizin | Meppen | 49716 | Germany |
| KLINIKUM VEST GMBH Knappschaftskrankenhaus Klinik für Radiologie und Neuroradiologie | Recklinghausen | 45657 | Germany |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |