Evaluating the safety and effectiveness of the Accero® stent for treating brain aneurysms
Evaluation of Safety and Efficacy of the Accero® (Heal) Stent for Intracranial Aneurysm Treatment
Acandis GmbH · NCT03957382
This study is testing how safe and effective the Accero® stent is for treating brain aneurysms in patients who receive it as directed.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Sex | All |
| Sponsor | Acandis GmbH (industry) |
| Locations | 4 sites (Berlin and 3 other locations) |
| Trial ID | NCT03957382 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and efficacy of the Accero® (Heal) stent in patients with intracranial aneurysms. Participants will be those treated with the stent according to its instructions for use, and they will provide informed consent to be part of the evaluation. The study will monitor outcomes related to the stent's performance and any associated safety concerns. The findings will contribute to understanding the stent's role in managing this condition.
Who should consider this trial
Good fit: Ideal candidates are patients who have been treated with the Accero® (Heal) stent and have given informed consent.
Not a fit: Patients currently participating in another clinical trial will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, safe treatment option for patients with intracranial aneurysms.
How similar studies have performed: While this study focuses on a specific stent, similar approaches in evaluating stents for aneurysm treatment have shown promise in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Berlin and 3 other locations
- Vivantes - Klinikum Neukölln Institut für klinische und interventionelle Neuroradiologie — Berlin, Germany (RECRUITING)
- Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany (RECRUITING)
- Krankenhaus Ludmillenstift, Abteilung für Radiologie, Neuroradiologie und Nuklearmedizin — Meppen, Germany (RECRUITING)
- KLINIKUM VEST GMBH Knappschaftskrankenhaus Klinik für Radiologie und Neuroradiologie — Recklinghausen, Germany (RECRUITING)
Study contacts
- Principal investigator: Maxim Bester, PD. Dr. — Universitätsklinikum Hamburg-Eppendorf
- Study coordinator: Acandis GmbH
- Email: info@acandis.com
- Phone: +49 7231 155 00 0
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Intracranial Aneurysm