Registry for the use of Credo® stent in treating intracranial stenosis
AcandiS Stenting of Intracranial STENosis - regisTry
This study is tracking how well the Credo® stent and NeuroSpeed® balloon catheter work for people with narrowed brain arteries and whether they are safe to use.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Acandis GmbH Industry-sponsored |
| Locations | 16 sites (Bochum and 15 other locations) |
| Trial ID | NCT03902444 on ClinicalTrials.gov |
What this trial studies
This registry collects detailed information on the safety and effectiveness of the Credo® stent and NeuroSpeed® PTA balloon catheter in patients with intracranial stenosis. It involves recording data from routine clinical practice during treatment and includes a follow-up visit 30 days post-procedure. The study aims to assess technical success, complications, and overall clinical outcomes associated with these interventions. Data collected will help improve understanding of the treatment's impact in real-world settings.
Who should consider this trial
Good fit: Ideal candidates are patients with symptomatic atherosclerotic intracranial artery stenosis who are undergoing treatment with the Credo® stent.
Not a fit: Patients who do not have symptomatic atherosclerotic intracranial artery stenosis may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could enhance the safety and efficacy of stenting procedures for patients with intracranial stenosis.
How similar studies have performed: Other studies have shown success with similar stenting approaches, indicating potential for positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: - Treatment with Credo® for symptomatic atherosclerotic intracranial artery stenosis (see product IFU) Exclusion Criteria: * There are no specific exclusion criteria (see product IFU)
Where this trial is running
Bochum and 15 other locations
- Universitätsklinikum Knappschaftskrankenhaus Bochum — Bochum, Germany (Recruiting)
- Universitätsklinikum Düsseldorf Institut für Diagnostische und Interventionelle Radiologie Abteilung Neuroradiologie — Düsseldorf, Germany (Recruiting)
- Alfried Krupp Krankenhaus Essen, Klinik für Neuroradiologie — Essen, Germany (Recruiting)
- Institut für Diagnostische und Interventionelle Neuroradiologie Universitätsmedizin Göttingen — Göttingen, Germany (Recruiting)
- Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany (Recruiting)
- Asklepios Klinik Altona, Fachbereich Neuroradiologie — Hamburg, Germany (Recruiting)
- Universitätsklinikum Heidelberg Abteilung für Neuroradiologie — Heidelberg, Germany (Recruiting)
- Universitätsklinikum Homburg — Homburg, Germany (Recruiting)
- Klinikum Ingolstadt — Ingolstadt, Germany (Recruiting)
- Uniklinik Köln — Köln, Germany (Recruiting)
- Otto-von-Guericke-Universität Magdeburg Universitätsklinik für Neuroradiologie — Magdeburg, Germany (Recruiting)
- Kliniken Maria Hilf GmbH Mönchengladbach, Klinik für Diagnostische und Interventionelle Radiologie und Neuroradiologie — Mönchengladbach, Germany (Recruiting)
- Evangelisches Krankenhaus Oldenburg; Medizinischer Campus Universität Oldenburg — Oldenburg, Germany (Recruiting)
- Klinikum Osnabrück, Klinik für Neurologie — Osnabrück, Germany (Recruiting)
- KLINIKUM VEST GMBH Knappschaftskrankenhaus Klinik für Radiologie und Neuroradiologie — Recklinghausen, Germany (Recruiting)
- St. Lukas Klinik GmbH, radprax MVZ GmbH Solingen — Solingen, Germany (Recruiting)
Study contacts
- Principal investigator: Götz Thomalla, MD — Unversity Medical Center Hamburg-Eppendorf
- Study coordinator: Acandis GmbH
- Email: info@acandis.com
- Phone: +49 723 1155 00
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.