A Single-arm Trial of the Flow Diverter (Tonbridge) For Endovascular Treatment of Intracranial Aneurysms

NCT04918420 | Completed

• 1 other identifier: ZHTQ2021002
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to assess the effectiveness and safety of the Flow Diverter (Tonbridge) by collecting data from subjects who receive endovascular treatment of intracranial aneurysms.

Conditions

Intracranial Aneurysm

Outcome Measures

Primary Outcomes (1)

• Complete occlusion rate of aneurysms at 12 months

  Complete occlusion is defined as no contrast agent in the aneurysm (Raymond-Roy class I) which is diagnosed by cerebrovascular DSA at 12 months post-procedure.

  360±30 days post-procedure

Secondary Outcomes (13)

• Immediate procedural success rate

  intra-procedure

• Complete occlusion rate of aneurysms at 6 months

  180±30 days post-procedure

• Successful occlusion rate of aneurysms at 12 months

  360±30 days post-procedure

• Incidence of new-onset stroke in the territory supplied by the treated artery or neurologic death at 12 months

  360±30 days post-procedure

• Incidence of technical complications

  intra-procedure

Study Arms (1)

Flow Diverter (Tonbridge)

EXPERIMENTAL

Treatment with Flow Diverter (Tonbridge)

Device: Flow Diverter (Tonbridge)

Interventions

Flow Diverter (Tonbridge) DEVICE

The device is a self-expanding vascular stent system, which consists of a stent and a delivery system. The stent is made of platinum core nickel-titanium alloy material. The delivery system is composed of a delivery guide wire and an introducer sheath. The stent and the delivery guide wire are pre-installed in the introducer sheath.

Flow Diverter (Tonbridge)

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;
• A single unruptured intracranial aneurysm locates in the intracranial segment of internal carotid artery (ICA) or vertebral artery (VA), which diagnosed by DSA;
• The maximal diameter of the target aneurysm \< 10 mm diagnosed by DSA;
• The target aneurysm with a neck ≥ 4 mm or a dome to neck ratio \< 2 diagnosed by DSA;
• The target aneurysm with a parent vessel diameter of 2.0-6.5 mm;
• Subject or guardian is able to understand the purpose of study, shows sufficient compliance with the study protocol and provides a signed informed consent form.

You may not qualify if:

• Diagnosed as with cerebrovascular malformations;
• Intracranial hemorrhage within 30 days pre-procedure;
• Modified Rankin Scale (mRS) score ≥ 3 in pre-procedure;
• Platelet (PLT) \< 60×10\^9/L or known platelet dysfunction or International Normalized Ratio (INR) \> 1.5;
• Heart, lung, liver and renal failure or other severe diseases (such as intracranial tumor, systemic infection, disseminated intravascular coagulation, myocardial infarction within 12 months before enrollment, history of severe psychosis, severe stenosis or occlusion of cerebral feeding artery);
• Subject who is not appropriate for flow diverter delivery and deployment judged by investigators (severe stenosis of parent artery, severe tortuosity of parent artery, stent failing to reach the lesion, stent in the target lesion of parent artery, etc.);
• Major surgery within 30 days before enrollment, or intending to receive surgery within 180 days after enrollment;
• Allergic history of anesthetics and contrast agents, or contraindication for dual antiplatelet or/and anticoagulant therapy;
• Allergic history of metals such as nickel-titanium alloy;
• Life expectancy \< 12 months;
• Pregnant or breastfeeding women;
• Subject has participated in other drug or medical device clinical trials within 1 month before signing informed consent;
• Other conditions judged by the investigators as unsuitable for enrollment.

Sponsors & Collaborators

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

Study Sites (7)

The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Location

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Location

Zhejiang Hospital

Hangzhou, Zhejiang, China

Location

Xinqiao Hospital, Army Medical University

Chongqing, China

Location

Changhai Hospital of Shanghai

Shanghai, China

Location

Huashan Hospital Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jianmin Liu

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 8, 2021
• Study Start: July 7, 2021
• Primary Completion: March 9, 2023
• Study Completion: March 9, 2023
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

CN (7)