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

NCT06798740 | Recruiting

• 1 other identifier: CE-0005_CIP
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Aneurysm

Keywords

clip; sugita

Outcome Measures

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".

  Up to 12 months

Secondary Outcomes (5)

• Incidence of adverse events

  up to 60 months

• Change in Modified Rankin Scale

  through 60 months

• Amount of aneurysm retreatments

  through 60 months

• Procedure success rate

  within 1 week after clipping

• Rate of successful applications of temporary clips

  Within 1 week after clipping

Study Arms (1)

Aneurysm clip

Patients presenting intracranial aneurysm (ruptured or unruptured) that the physician intends to treat with the Sugita clips.

Device: Sugita Titanium Aneurysm Clip II

Interventions

Sugita Titanium Aneurysm Clip II DEVICE

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

Aneurysm clip

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who have an intracranial aneurysm (ruptured or unruptured) that the physician intends to treat with the subject device(s)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mizuho Corporation: lead

Study Sites (1)

Universitätsklinikum Essen

Essen, D- 45122, Germany

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mai Hamayoshi

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 29, 2025
• Study Start: April 14, 2025
• Primary Completion (Estimated): February 14, 2027
• Study Completion (Estimated): February 14, 2033
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)