Efficacy and Safety of the Liquid Embolic System (Tonbridge) for Endovascular Treatment of Cerebrovascular Malformations

Официальное название

Efficacy and Safety of the Liquid Embolic System (Tonbridge) for Endovascular Treatment of Cerebrovascular Malformations: a Prospective, Multi-center, Randomized, Parallel Positive Controlled, Non-inferiority Trial

Обзор

The purpose of this study is to verify the efficacy and safety of the Liquid Embolic System (Tonbridge Medical Tech. Co., Ltd. (Suzhou)) for the treatment of cerebrovascular malformations.

Подробное описание

This is a prospective, multi-center, randomized, parallel positive controlled, non-inferiority trial. This clinical trial is conducted at more than 2 centers in China, and patients who intend to be treated with liquid embolic system for cerebrovascular malformations are enrolled. Eligible patients are randomized into experimental group using Liquid Embolic System (Tonbridge) or control group using Onyx Liquid Embolic System (Medtronic) in a 1:1 ratio. The purpose of this study is to evaluate the effectiveness and safety of the Liquid Embolic System (Tonbridge).

Вмешательства

• Устройство Liquid Embolic System (Tonbridge)
  Endovascular treatment with Liquid Embolic System (Tonbridge).
• Устройство Onyx Liquid Embolic System (Medtronic)
  Endovascular treatment with Onyx Liquid Embolic System (Medtronic).

Первичные конечные точки

• Targeted Embolization Satisfaction Rate [Срок оценки: intra-procedure]

Вторичные конечные точки (7)

• mRS score [Срок оценки: 1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure]
• GOS score [Срок оценки: 1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure]
• Operation satisfaction rate [Срок оценки: intra-procedure]
• Incidence of major adverse events (MAEs) [Срок оценки: 1 month±7 days, 3 months±30 days post-procedure]
• Incidence of adverse events (AEs) [Срок оценки: 1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure]
• Incidence of serious adverse events (SAEs) [Срок оценки: 1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure]
• Incidence of device deficiency [Срок оценки: 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure]

Критерии участия

Критерии включения

• Age 18 to 80 years, any gender;
• Subject is suitable for endovascular treatment of cerebrovascular malformations;
• Subject is able to understand the purpose of the study, shows sufficient compliance with the study protocol and provides a signed informed consent form.

Критерии исключения

• Intracranial hemorrhage within 1 month prior to treatment;
• The targeted embolization area needs to receive other treatments (surgical resection, SRS, other embolic materials) at the same time;
• Combination of other cerebrovascular malformations, such as cavernous vascular malformation;
• Severe stenosis or occlusion of cerebral feeding artery requiring surgical intervention;
• Intracranial tumor requiring surgical intervention;
• mRS score≥3;
• Heart, lung, liver and renal failure or other severe diseases;
• Known bleeding tendency, such as coagulation dysfunction (INR>1.5);
• Known allergy to DMSO and contrast media, or contraindication to anticoagulant therapy;
• Pregnant or breastfeeding women, or who plan to become pregnant during the study;
• Subject is participating in other drug or medical device clinical trials at the time of signing informed consent;
• Other conditions judged by the investigators as unsuitable for enrollment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 14 центров

• Nanfang Hospital Southern Medical University — Гуанчжоу
• Zhujiang Hospital of Southern Medical University — Гуанчжоу
• Henan Provincial People's Hospital — Чжэнчжоу
• The First Affiliated Hospital of Zhengzhou University — Чжэнчжоу
• General Hospital of Eastern Theater Command — Нанкин
• The First Hospital of Jilin University — Changchun
• General Hospital of Northern Theater Command — Шэньян
• Qilu Hospital of Shandong University — Цзинань
• … и ещё 6 центров

Идентификаторы

NCT: NCT06479343 · SZTQ202401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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