Evaluation of Safety and Efficacy of the Accero® (Heal) Stent for Intracranial Aneurysm Treatment
1 other identifier
observational
130
1 country
4
Brief Summary
This study is intended to show that the application of the Accero® (heal) stent is safe within the given indication.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2019
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2019
CompletedFirst Posted
Study publicly available on registry
May 21, 2019
CompletedStudy Start
First participant enrolled
July 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2029
November 21, 2025
November 1, 2025
9.6 years
May 16, 2019
November 18, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (4)
modified Rankin Scale (mRS)
6 months after treatment
modified Rankin Scale (mRS)
12 months after treatment
modified Rankin Scale (mRS)
24 months after treatment
modified Rankin Scale (mRS)
36 months after treatment
Interventions
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.
Eligibility Criteria
All patients treated with Accero® (heal) Stent
You may qualify if:
- Any patient treated with ACCERO® (heal) Stent according to IFU and has signed the informed consent
You may not qualify if:
- \- Patient is participating in another clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Acandis GmbHlead
Study Sites (4)
Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Universitätsklinikum Hamburg-Eppendorf
Hamburg, Hamburg, 20246, Germany
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maxim Bester, PD. Dr.
Universitätsklinikum Hamburg-Eppendorf
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2019
First Posted
May 21, 2019
Study Start
July 23, 2019
Primary Completion (Estimated)
March 1, 2029
Study Completion (Estimated)
March 1, 2029
Last Updated
November 21, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share