Post Market Registry Study of Intracranial Aneurysms Treated With Sugita Clipping Devices
ConditionBrain Aneurysm
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMizuho Corporation
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Sugita Titanium Aneurysm Clip II
Treatment groups
150 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov