Evaluation of a Novel Intrasaccular Embolization Device for the Treatment of Intracranial Aneurysms

NCT ID: NCT07022249

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2027-06-30

Brief Summary

The study is a prospective, multicenter single-arm cohort. The purpose of this study is to evaluate efficacy and safety of a novel intrasaccular embolization device for the treatment of intracranial aneurysms.

Conditions

Intracranial Aneurysms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Group

Intrasaccular Embolization Device

Group Type: EXPERIMENTAL

Intrasaccular Embolization Device

Intervention Type: DEVICE

This is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.The intended therapeutic effect of this device is to line the neck of the aneurysm with a metallic structure that disrupts the inflow of blood, causing hemostasis within the aneurysm sac, and leading to thrombus formation within the implant.

Interventions

Intrasaccular Embolization Device

This is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.The intended therapeutic effect of this device is to line the neck of the aneurysm with a metallic structure that disrupts the inflow of blood, causing hemostasis within the aneurysm sac, and leading to thrombus formation within the implant.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient must be 18-75 years of age at the time of screening.
• Patient must have a single ruptured or unruptured IA requiring treatment.
• Patient was able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule, signed and dated an written informed consent prior to initiation of any study procedures.

Exclusion Criteria

• Patient had an IA with characteristics unsuitable for endovascular treatment.
• Patient had vessel characteristics, tortuosity or morphology which precluded safe access and support during treatment with study device.
• Patient had vascular disease or other vascular anomaly that precluded the necessary access to the aneurysm for use of the study device.
• Patient had vasculitis, an intracranial tumor (except benign tumors that do not require treatment) or any other intracranial vascular malformations on presentation.
• Patient was taking anticoagulants or had a known blood dyscrasia, coagulopathy, or hemoglobinopathy.
• Patient was pregnant.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ton-Bridge Medical Tech. Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Xiaoyan Yang

Role: CONTACT

xy.yang@ton-bridge.com

18577072001

Other Identifiers

ZHTQ202501

Identifier Type: -

Identifier Source: org_study_id