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

NCT06479343 | Recruiting

• 1 other identifier: SZTQ202401
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 14

Brief Summary

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.

Conditions

Intracranial Arteriovenous Malformations

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• mRS score

  1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure

• GOS score

  1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure

• Operation satisfaction rate

  intra-procedure

• Incidence of major adverse events (MAEs)

  1 month±7 days, 3 months±30 days post-procedure

• Incidence of adverse events (AEs)

  1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure

Study Arms (2)

Liquid Embolic System (Tonbridge)

EXPERIMENTAL

Device: Liquid Embolic System (Tonbridge)

Onyx Liquid Embolic System (Medtronic)

ACTIVE COMPARATOR

Device: Onyx Liquid Embolic System (Medtronic)

Interventions

Liquid Embolic System (Tonbridge) DEVICE

Endovascular treatment with Liquid Embolic System (Tonbridge).

Liquid Embolic System (Tonbridge)

Onyx Liquid Embolic System (Medtronic) DEVICE

Endovascular treatment with Onyx Liquid Embolic System (Medtronic).

Onyx Liquid Embolic System (Medtronic)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (14)

Nanfang Hospital Southern Medical University

Guangzhou, Guangdong, China

NOT YET RECRUITING

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

NOT YET RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, China

NOT YET RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

ACTIVE NOT RECRUITING

General Hospital of Eastern Theater Command

Nanjing, Jiangsu, China

NOT YET RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, China

NOT YET RECRUITING

General Hospital of Northern Theater Command

Shenyang, Liaoning, China

NOT YET RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, China

NOT YET RECRUITING

Xuanwu hospital Capital Medical University

Beijing, China

RECRUITING

Sichuan Academy of Medical Sciences Sichuan Provincial People's Hospital

Chengdu, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, China

NOT YET RECRUITING

Anhui Provincial Hospital

Hefei, China

NOT YET RECRUITING

Jining No.1 People's Hospital

Jining, China

NOT YET RECRUITING

Tongji Hospital Tongji Medical College of HUST

Wuhan, China

NOT YET RECRUITING

MeSH Terms

Conditions

Intracranial Arteriovenous Malformations

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Central Nervous System Vascular Malformations; Nervous System Malformations; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Intracranial Arterial Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Peng Zhang

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Pan

CONTACT

18916099975; jing.pan@ton-bridge.com

Jin Zheng

CONTACT

Study Design

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

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 28, 2024
• Study Start: June 27, 2024
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (14)