Evaluation of Safety and Efficacy of the Accero® (Heal) Stent for Intracranial Aneurysm Treatment

Recruiting

• Conditions: Intracranial Aneurysm

• Registration Number: NCT03957382
• Lead Sponsor: Acandis GmbH

Brief Summary

This study is intended to show that the application of the Accero® (heal) stent is safe within the given indication.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-16
• Study First Submitted QC: 2019-05-17
• Study First Posted: 2019-05-21
• Study Start: 2019-07-23
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-05
• Primary Completion: 2026-09-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Raymond Roy Classification	36 months after treatment	Assessment of Raymond Roy Classification

Secondary Outcome Measures

Name	Time	Method
modified Rankin Scale (mRS)	36 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.

Trial Locations

Locations (4)

Vivantes - Klinikum Neukölln Institut für klinische und interventionelle Neuroradiologie; 🇩🇪 Berlin, Germany

Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

KLINIKUM VEST GMBH Knappschaftskrankenhaus Klinik für Radiologie und Neuroradiologie; 🇩🇪 Recklinghausen, Germany

Krankenhaus Ludmillenstift, Abteilung für Radiologie, Neuroradiologie und Nuklearmedizin; 🇩🇪 Meppen, Germany