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

Launched by TON-BRIDGE MEDICAL TECH. CO., LTD · Jun 8, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new device designed to treat intracranial aneurysms, which are bulges in blood vessels in the brain that can be dangerous if they rupture. The goal of the study is to see how effective and safe this device is for patients with these aneurysms. The trial is currently not recruiting participants, but when it begins, it will include adults aged 18 to 75 who have either a ruptured or unruptured aneurysm that needs treatment.

To participate, individuals must meet certain criteria, such as being willing to follow the study’s procedures and provide written consent. However, some people will not be eligible, including those with certain health conditions that make the aneurysm unsuitable for treatment with this device or those who are pregnant. Participants will be monitored closely throughout the study to ensure their safety and to gather important information about how well the device works. This trial could help advance treatment options for people with intracranial aneurysms.

Gender

ALL

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.