Post Market Registry Study of Intracranial Aneurysms Treated With Sugita Clipping Devices (T2_PMCF)

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 Overview

• Status: Recruiting
• Conditions: Brain Aneurysm
• Intervention / Treatment: Device: Sugita Titanium Aneurysm Clip II

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Mai Hamayoshi; Phone Number: +81-3-3815-3180; Email: m.hamayoshi@mizuho.co.jp

Study Locations

• Germany
  • Essen, Germany, D- 45122
    • Recruiting
    • Universitatsklinikum Essen
    • Contact: Ulrich Sure, MD; Phone Number: +49 201 / 723-84208

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Aneurysm clipping is a surgical procedure used to treat brain aneurysms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Mizuho Corporation

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2025
• Primary Completion (Estimated): February 14, 2027
• Study Completion (Estimated): February 14, 2033

Study Registration Dates

• First Submitted: January 23, 2025
• First Submitted That Met QC Criteria: January 23, 2025
• First Posted (Actual): January 29, 2025

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: clip; sugita
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: CE-0005_CIP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No