Post Market Registry Study of Intracranial Aneurysms Treated With Sugita Clipping Devices

Mizuho Corporation150 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Brain Aneurysm

Interventions

Sugita Titanium Aneurysm Clip IIDEVICE

Aneurysm clipping is a surgical procedure used to treat brain aneurysms.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Universitätsklinikum Essen

Essen, Germany

RECRUITING

Outcomes

Primary Outcomes

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 months

Secondary Outcomes

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 months

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 months

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 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.

Time frame: 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.

Time frame: Within 1 week after clipping

Central Contacts

Mai Hamayoshi

CONTACT

+81-3-3815-3180 m.hamayoshi@mizuho.co.jp

Data from ClinicalTrials.gov

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