Post Market Registry Study of Intracranial Aneurysms Treated With Sugita Clipping Devices

Not yet recruiting

• Conditions: Brain Aneurysm

• Registration Number: NCT06798740
• Lead Sponsor: Mizuho Corporation

Brief Summary

The objective of this study is to verify the performance and safety of the Sugita Aneurysm Clips devices when used as intended and to identify possible risk factors. Data collected will be used to support the continuing performance and safety of the devices in the post-market use environment in Europe. Subjects who have an intracranial aneurysm that the physician intends to treat with the subject devices will be included in the study. Subjects will be followup as per hospital standard of care for 5 years.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-23
• Study First Submitted QC: 2025-01-23
• Last Update Submitted: 2025-01-23
• Study First Posted: 2025-01-29
• Last Update Posted: 2025-01-29
• Study Start: 2025-02-15
• Primary Completion: 2027-02-14
• Study Completion: 2033-02-14

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Subject has an intracranial aneurysm (ruptured or unruptured) that can be treated with one of the proposed devices.
• Subject is adult, ≥18 years.
• As per national regulations, subject or subject's legally authorized representative (LAR) has signed written informed consent.
• Subject is willing to comply with scheduled visits and examinations per institutional standard of care.

Exclusion Criteria

• Subject is currently enrolled in or plans to be enrolled in a concurrent drug or device randomized study.
• Subject has a condition which will not allow him/her to comply with his/her post-procedure follow up per the institutional standard of care (medical condition, subject living abroad and unable to return for follow- up, e.g.).
• Subject does not meet IFU criteria of the subject device.
• Subject is a child, <18 years.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Permanent aneurysm occlusion	Up to 12 months	Rate of complete permanent aneurysm occlusion

Secondary Outcome Measures

Name	Time	Method
Adverse events	up to 60 months	Incidence of adverse events post- procedure
mRS	through 60 months	Modified Rankin Scale post- procedure
Aneurysm retreatment	through 60 months	Target aneurysm retreatment
Procedure success	within 1 week after clipping	Rate of successful aneurysm occlusion

Trial Locations

Locations (1)

Universitätsklinikum Essen; 🇩🇪 Essen, Germany