Efficacy and Safety of the Self-expanding Intracranial Stent (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms

Ton-Bridge Medical Tech. Co., Ltd

Status: Completed

Conditions: Intracranial Aneurysm

Treatments: Device: Self-expanding Intracranial Stent (Tonbridge); Device: LVIS and LVIS Jr. (MicroVention)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05755516

ZHTQ202202

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and safety of Self-expanding Intracranial Stent (Tonbridge), by comparing the data obtained from Self-expanding Intracranial Stent (Zhuhai Tonbridge Medical Tech. Co., Ltd.) and LVIS/LVIS Jr. (MicroVention Europe SARL) for endovascular treatment of intracranial aneurysms.

Full description

This is a prospective, multi-center, randomized, open, 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 stent-assisted coiling for intracranial aneurysms are enrolled. Eligible patients are randomized into experimental group using Self-expanding Intracranial Stent (Tonbridge) or control group using LVIS and LVIS Jr. (MicroVention) in a 1:1 ratio. The purpose of this study is to evaluate the effectiveness and safety of the Self-expanding Intracranial Stent (Tonbridge).

Enrollment: 204 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 to 80 years, any gender;
• Diagnosed as intracranial aneurysm and the subject is assessed as suitable for stent-assisted coiling;
• 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.

Exclusion criteria

• Aneurysm rupture within 30 days before enrollment;
• Diagnosed as blood blister-like aneurysm, pseudoaneurysm, infected aneurysm, or aneurysm related to arteriovenous malformations;
• Conditions that are not appropriate for stent 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.);
• Modified Rankin Scale (mRS) score ≥3;
• Heart, lung, liver and renal failure or other severe diseases (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, etc.);
• Major surgery within 30 days before enrollment；
• Known coagulation dysfunction or contraindication to anticoagulant and antiplatelet therapy;
• Known allergy to nickel-titanium alloy metal materials;
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 2 patient groups

experimental group

Experimental group

Description:

Self-expanding Intracranial Stent (Tonbridge)

Treatment:

Device: Self-expanding Intracranial Stent (Tonbridge)

control group

Active Comparator group

Description:

LVIS and LVIS Jr. (MicroVention)

Treatment:

Device: LVIS and LVIS Jr. (MicroVention)