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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aneurysm clip | Patients presenting intracranial aneurysm (ruptured or unruptured) that the physician intends to treat with the Sugita clips. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugita Titanium Aneurysm Clip II | Device | Aneurysm clipping is a surgical procedure used to treat brain aneurysms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of permanent aneurysm occlusions | Rate of complete permanent aneurysm occlusions according to Molyneux et al, 2005, where the category of occlusion is selected as "Complete occlusion". | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | The number and percentage of subjects experiencing any adverse event. Each adverse event type, including severity will be reported. | up to 60 months |
| Change in Modified Rankin Scale |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who have an intracranial aneurysm (ruptured or unruptured) that the physician intends to treat with the subject device(s)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mai Hamayoshi | Contact | +81-3-3815-3180 | m.hamayoshi@mizuho.co.jp |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Essen | Recruiting | Essen | D- 45122 | Germany |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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.
| through 60 months |
| Amount of aneurysm retreatments | The amount of aneurysm retreatments will be reported as 0, 1 and >=2 retreatments through each follow up visit. | through 60 months |
| Procedure success rate | 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. | within 1 week after clipping |
| Rate of successful applications of temporary clips | Subjects that experience a successful aneurysm occlusion according to Molyneux classification "Complete occlusion" while using temporary clips. | Within 1 week after clipping |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |