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

Intracranial Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03957382
• Other study ID #: 1041-1
• Status: Recruiting
• Start date: July 23, 2019
• Est. completion date: December 31, 2026

Study information

• Verified date: September 2023
• Source: Acandis GmbH
• Contact: Acandis GmbH
• Phone: +49 7231 155 00 0
• Email: info[@]acandis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 31, 2026
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

All patients treated with Accero® (heal) Stent according to IFU

Exclusion Criteria:

• mRS > 2

• Hunt and Hess >3 (in patients with subarachnoid hemorrhage-SAH)

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Germany	Vivantes - Klinikum Neukölln Institut für klinische und interventionelle Neuroradiologie	Berlin
Germany	Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Krankenhaus Ludmillenstift, Abteilung für Radiologie, Neuroradiologie und Nuklearmedizin	Meppen
Germany	KLINIKUM VEST GMBH Knappschaftskrankenhaus Klinik für Radiologie und Neuroradiologie	Recklinghausen

Sponsors (1)

Lead Sponsor	Collaborator
Acandis GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Raymond Roy Classification	Assessment of Raymond Roy Classification	6 months after treatment
Primary	Raymond Roy Classification	Assessment of Raymond Roy Classification	12 months after treatment
Primary	Raymond Roy Classification	Assessment of Raymond Roy Classification	24 months after treatment
Primary	Raymond Roy Classification	Assessment of Raymond Roy Classification	36 months after treatment
Secondary	modified Rankin Scale (mRS)	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.; - No significant disability. Able to carry out all usual activities, despite some symptoms.; - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; - Moderate disability. Requires some help, but able to walk unassisted.; - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; - Dead.	6 months after treatment
Secondary	modified Rankin Scale (mRS)	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.; - No significant disability. Able to carry out all usual activities, despite some symptoms.; - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; - Moderate disability. Requires some help, but able to walk unassisted.; - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; - Dead.	12 months after treatment
Secondary	modified Rankin Scale (mRS)	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.; - No significant disability. Able to carry out all usual activities, despite some symptoms.; - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; - Moderate disability. Requires some help, but able to walk unassisted.; - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; - Dead.	24 months after treatment
Secondary	modified Rankin Scale (mRS)	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.; - No significant disability. Able to carry out all usual activities, despite some symptoms.; - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; - Moderate disability. Requires some help, but able to walk unassisted.; - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; - Dead.	36 months after treatment