Post Market Registry Study of Intracranial Aneurysms Treated With Sugita Clipping Devices
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sugita Titanium Aneurysm Clip II.
- Who it may be relevant to
- Registry conditions: Brain Aneurysm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Sugita Titanium Aneurysm Clip II
Aneurysm clipping is a surgical procedure used to treat brain aneurysms.
Primary outcome measures
- Rate of permanent aneurysm occlusions [Time frame: Up to 12 months]
Secondary outcome measures (5)
- Incidence of adverse events [Time frame: up to 60 months]
- Change in Modified Rankin Scale [Time frame: through 60 months]
- Amount of aneurysm retreatments [Time frame: through 60 months]
- Procedure success rate [Time frame: within 1 week after clipping]
- Rate of successful applications of temporary clips [Time frame: Within 1 week after clipping]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Universitätsklinikum Essen — Essen
Identifiers
NCT: NCT06798740 · CE-0005_CIP