Brain Aneurysm
Conditions
Keywords
clip, sugita
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.
Interventions
DEVICESugita Titanium Aneurysm Clip II
Aneurysm clipping is a surgical procedure used to treat brain aneurysms.
Sponsors
Mizuho Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of permanent aneurysm occlusions | Up to 12 months | Rate of complete permanent aneurysm occlusions according to Molyneux et al, 2005, where the category of occlusion is selected as "Complete occlusion". |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | up to 60 months | The number and percentage of subjects experiencing any adverse event. Each adverse event type, including severity will be reported. |
| Change in Modified Rankin Scale | through 60 months | The mean, standard deviation, median, minimum, maximum, and number of evaluable observations will be reported for baseline and to each follow up visit using descriptive statistics.The absolute change from baseline will be calculated for each subject at follow up visits. |
| Amount of aneurysm retreatments | through 60 months | The amount of aneurysm retreatments will be reported as 0, 1 and \>=2 retreatments through each follow up visit. |
| Procedure success rate | within 1 week after clipping | Rate of successful aneurysm occlusions per Molyneux classification "Complete occlusion" while using a permanent clip. Frequency counts and percentages of subjects, as well as 95% confidence intervals for the percentages will be presented. |
| Rate of successful applications of temporary clips | Within 1 week after clipping | Subjects that experience a successful aneurysm occlusion according to Molyneux classification "Complete occlusion" while using temporary clips. |
Countries
Germany
Contacts
CONTACTMai Hamayoshi
Outcome results
None listed