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

Ton-Bridge Medical Tech. Co., Ltd

Status

Not yet enrolling

Conditions

Intracranial Aneurysms

Treatments

Device: Intrasaccular Embolization Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT07022249

ZHTQ202501

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.