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NCT Number: NCT06798740

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

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.

Recruiting

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Key information

Conditions

Brain Aneurysm Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Aneurysm Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Essen

Essen, D- 45122, Germany

Location status: Recruiting

Location contact

Ulrich Sure, MD

CONTACT

+49 201 / 723-84208

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sugita Titanium Aneurysm Clip II

Device

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

Primary outcomes

  1. Rate of permanent aneurysm occlusions

    Time frame: 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 outcomes

  1. Incidence of adverse events

    Time frame: up to 60 months

    The number and percentage of subjects experiencing any adverse event. Each adverse event type, including severity will be reported.

  2. Change in Modified Rankin Scale

    Time frame: 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.

  3. Amount of aneurysm retreatments

    Time frame: through 60 months

    The amount of aneurysm retreatments will be reported as 0, 1 and >=2 retreatments through each follow up visit.

  4. Procedure success rate

    Time frame: 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.

  5. Rate of successful applications of temporary clips

    Time frame: Within 1 week after clipping

    Subjects that experience a successful aneurysm occlusion according to Molyneux classification "Complete occlusion" while using temporary clips.

Study contacts

Contact information is provided by the study sponsor or research team.

Mai Hamayoshi

CONTACT

[email protected]

+81-3-3815-3180

Sponsors and collaborators

Lead sponsor

Mizuho Corporation

Other

Registry information

Acronym: T2_PMCF

Important dates

Study start
2025
Primary completion
2027
Study completion
2033
First posted
Jan 29, 2025
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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