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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intracranial Arteriovenous Malformations
• Intervention / Treatment: Device: Liquid Embolic System (Tonbridge); Device: Onyx Liquid Embolic System (Medtronic)

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jing Pan; Phone Number: 18916099975; Email: jing.pan@ton-bridge.com
• Study Contact Backup: Name: Jin Zheng

Study Locations

• China
  • Beijing, China
    • Xuanwu Hospital Capital Medical University
    • Contact: Peng Zhang
  • Chengdu, China
    • Sichuan Academy of Medical Sciences Sichuan Provincial People's Hospital
    • Principal Investigator: Tian Zhang
  • Guangzhou, China
    • Guangdong Provincial People's Hospital
    • Principal Investigator: Guangzhong Chen
  • Hefei, China
    • Anhui Provincial Hospital
    • Principal Investigator: Ge Gao
  • Jining, China
    • Jining No.1 People's Hospital
    • Principal Investigator: Feng Lei
  • Wuhan, China
    • Tongji Hospital Tongji Medical College Of Hust
  • Guangdong
    • Guangzhou, Guangdong, China
      • Nanfang Hospital Southern Medical University
    • Guangzhou, Guangdong, China
      • Zhujiang Hospital of Southern Medical University
  • Henan
    • Zhengzhou, Henan, China
      • The First Affiliated Hospital of Zhengzhou University
    • Zhengzhou, Henan, China
      • Henan Provincial People's Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China
      • General Hospital of Eastern Theater Command
  • Jilin
    • Changchun, Jilin, China
      • The First Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China
      • General Hospital of Northern Theater Command
  • Shandong
    • Jinan, Shandong, China
      • Qilu Hospital of Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liquid Embolic System (Tonbridge)	Device: Liquid Embolic System (Tonbridge); Endovascular treatment with Liquid Embolic System (Tonbridge).
Active Comparator: Onyx Liquid Embolic System (Medtronic)	Device: Onyx Liquid Embolic System (Medtronic); Endovascular treatment with Onyx Liquid Embolic System (Medtronic).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Targeted Embolization Satisfaction Rate	Targeted embolization satisfaction is defined as achieving ≥50% occlusion of the targeted embolized area after treatment with liquid embolic system, which is determined by immediate postoperative cerebrovascular DSA.	intra-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mRS score	mRS scores are assessed at each evaluation time point.	1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure
GOS score	GOS scores are assessed at each evaluation time point.	1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure
Operation satisfaction rate	The 5-point Likert scale is used to evaluate operation satisfaction from three aspects: visualization, diffusion, and microcatheter withdrawal. "Operation satisfaction rate" is defined as the proportion of investigational devices or comparators with Likert score≥12 points.	intra-procedure
Incidence of major adverse events (MAEs)	MAEs are defined as intracranial hemorrhage and ischemic complications. Intracranial hemorrhage included intraoperative hemorrhage (puncture of blood-supplying arteries by catheters or guidewires, rupture of nidus, and injury to blood vessels during withdrawal of catheters) and delayed symptomatic hemorrhage in the postoperative period; and ischemic complications included intraoperative ischemic complications (displacement of liquid embolic agents, thrombosis, and so on) and postoperative symptomatic ischemic stroke. "Incidence of major adverse events" is the proportion of subjects with adverse events using the investigational device or the comparator.	1 month±7 days, 3 months±30 days post-procedure
Incidence of adverse events (AEs)	"Incidence of adverse events" is the proportion of subjects with adverse events using the investigational device or the comparator.	1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure
Incidence of serious adverse events (SAEs)	"Incidence of serious adverse events" is the proportion of subjects with serious adverse events using the investigational device or the comparator.	1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure
Incidence of device deficiency	Device deficiency is the unreasonable risk that may endanger human health and life safety in the normal use of medical devices during clinical trials, such as labeling errors, quality problems and malfunctions.	3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure

Collaborators and Investigators

• Sponsor: Zhuhai Tonbridge Medical Tech. Co., Ltd.
• Investigators: Principal Investigator: Peng Zhang, Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: June 24, 2024
• First Posted (Actual): June 28, 2024

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 24, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cardiovascular Abnormalities; Nervous System Malformations; Vascular Malformations; Intracranial Arterial Diseases; Central Nervous System Vascular Malformations; Congenital Abnormalities; Arteriovenous Malformations; Intracranial Arteriovenous Malformations
• Other Study ID Numbers: SZTQ202401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No