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
This trial does not accept healthy volunteersQualifiers
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 population
Subjects who have an intracranial aneurysm (ruptured or unruptured) that the physician intends to treat with the subject device(s)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Sugita Titanium Aneurysm Clip II
DeviceAneurysm clipping is a surgical procedure used to treat brain aneurysms.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Aneurysm clip1 intervention
Trial outcomes
Primary outcomes
1
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".
Time frame
Up to 12 monthsSecondary outcomes
1
Incidence of adverse events
The number and percentage of subjects experiencing any adverse event. Each adverse event type, including severity will be reported.
Time frame
up to 60 months2
Change in Modified Rankin Scale
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.
Time frame
through 60 months3
Amount of aneurysm retreatments
The amount of aneurysm retreatments will be reported as 0, 1 and \>=2 retreatments through each follow up visit.
Time frame
through 60 months4
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.
Time frame
within 1 week after clippingSponsors and contacts
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Source ClinicalTrials.gov