Intracranial Aneurysm
Conditions
Brief summary
This study is intended to show that the application of the Accero® (heal) stent is safe within the given indication.
Interventions
DEVICEAccero® (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.
Sponsors
Acandis GmbH
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Raymond Roy Classification | 6 months after treatment | Assessment of Raymond Roy Classification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| modified Rankin Scale (mRS) | 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. |
Countries
Germany
Outcome results
None listed