Post Market Registry Study of Intracranial Aneurysms Treated With Sugita Clipping Devices (T2 PMCF)

Mizuho Corporation

Status

Not yet enrolling

Conditions

Brain Aneurysm

Treatments

Device: Sugita Titanium Aneurysm Clip II

Study type

Observational

Funder types

Other

Identifiers

NCT06798740

CE-0005_CIP

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.