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

NCT03957382 · tracked via the Priya Life Science Germany tracker

Sponsor

Acandis GmbH

Phase

Observational

Started

2019-07-23

Last updated

2025-11-21

Condition(s) studied

Intracranial Aneurysm

Investigational drug(s) / intervention(s)

Accero® (heal) Stent

Accero® (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.

Study summary

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

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Raymond Roy Classification — 6 months after treatment
Assessment of Raymond Roy Classification
Raymond Roy Classification — 12 months after treatment
Assessment of Raymond Roy Classification
Raymond Roy Classification — 24 months after treatment
Assessment of Raymond Roy Classification
Raymond Roy Classification — 36 months after treatment
Assessment of Raymond Roy Classification

Trial sites (4)

Facility	City	Region
Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Universitätsklinikum Hamburg-Eppendorf	Hamburg	Free and Hanseatic City of Hamburg
Vivantes - Klinikum Neukölln Institut für klinische und interventionelle Neuroradiologie	Berlin	Germany
Krankenhaus Ludmillenstift, Abteilung für Radiologie, Neuroradiologie und Nuklearmedizin	Meppen	Germany
KLINIKUM VEST GMBH Knappschaftskrankenhaus Klinik für Radiologie und Neuroradiologie	Recklinghausen	Germany

More Acandis GmbH trials in Germany

High Coverage CARotid Stenting vs. Medical Management Alone to Prevent EmboliSm From symptomaTic Non-stenotic cARotid Disease (SyNC) Recruiting

DERIVO® 2heal® Study: Clinical Safety and Efficacy of the DERIVO® 2heal® Embolisation Device Recruiting

REscue Stenting With CREDO® Heal for Recanalisation After Unsuccessful Thrombectomy (RECHRUT) Recruiting

Other trials for the same condition

FRED/ FRED Jr/ FRED X Intracranial Aneurysm Treatment Study Active, not recruiting

@neurIST : Intregrated Biomedical Informatics for the Management of Cerebral Aneurysms Recruiting

DERIVO® 2heal® Study: Clinical Safety and Efficacy of the DERIVO® 2heal® Embolisation Device Recruiting

LVIS™ Evo™ and HydroCoil® Embolic System for Intracranial Aneurysm Treatment Active, not recruiting

Safety and Efficacy of Silk Vista and Silk Vista Baby Flow Diverter for Intracranial Aneurysm Treatment Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03957382 on ClinicalTrials.gov ↗ ← All trials in Germany