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

NCT07022249 | Not Yet Recruiting

• 1 other identifier: ZHTQ202501
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• The Primary Safety Endpoint Included Any Death or Major Stroke in the First 30 Days and Neurologic Death or Ipsilateral Major Stroke Between Day 31 and Day 365.

  12 months

• Percentage of Subjects With Complete Aneurysm Occlusion Without Retreatment, Recurrent Subarachnoid Hemorrhage, Without Significant Parent Artery Stenosis (>50% Stenosis) at One Year After Treatment.

  12 months

Study Arms (1)

Experimental Group

EXPERIMENTAL

Intrasaccular Embolization Device

Device: Intrasaccular Embolization Device

Interventions

Intrasaccular Embolization Device 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.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ton-Bridge Medical Tech. Co., Ltd: lead

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

Xiaoyan Yang

CONTACT

18577072001; xy.yang@ton-bridge.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 15, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 15, 2025

Record last verified: 2025-06