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

Intracranial Aneurysm Clinical Trial

Official title:

Efficacy and Safety of the Self-expanding Intracranial Stent (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms: A Prospective, Multi-center, Randomized, Open, Parallel Positive Controlled, Non-inferiority Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05755516
• Other study ID #: ZHTQ202202
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: April 2025

Study information

• Verified date: March 2023
• Source: Zhuhai Tonbridge Medical Tech. Co., Ltd.
• Contact: Ben Han
• Phone: 17798683846
• Email: ben.han[@]ton-bridge.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 204
• Est. completion date: April 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• Self-expanding Intracranial Stent (Tonbridge)
Stent assisted coiling with Self-expanding Intracranial Stent (Tonbridge).
• LVIS and LVIS Jr. (MicroVention)
Stent assisted coiling with LVIS and LVIS Jr. (MicroVention).

Locations

Country	Name	City	State
China	Xiangya Hospital of Central South University	Changsha	Hunan
China	Sichuan Academy of Medical Sciences·Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	General Hospital of Eastern Theater Command	Nanjing	Jiangsu
China	Changhai Hospital of Shanghai	Shanghai
China	General Hospital of Northern Theater Command	Shenyang	Liaoning
China	First Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Tongji Hospital Tongji Medical College of HUST	Wuhan	Hubei
China	The First Affiliated Hospital of Wannan Medical College	Wuhu	Anhui
China	Zhuhai People's Hospital	Zhuhai	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhuhai Tonbridge Medical Tech. Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful occlusion rate of aneurysms at 6 months	Successful occlusion is defined as complete occlusion or neck remnant (Raymond-Roy class I or ?), which is diagnosed by cerebrovascular DSA at 6 months post-procedure.	6 months±30 days post-procedure
Secondary	Device success rate	Device success is that the stent is delivered to the target vessel successfully and covers the aneurysm neck effectively without stent migration or misplacement, etc. Device success is diagnosed by intraoperative cerebrovascular DSA.	intra-procedure
Secondary	Immediate successful occlusion rate of aneurysms	Successful occlusion is defined as complete occlusion or neck remnant (Raymond-Roy class I or ?), which is diagnosed by intraoperative cerebrovascular DSA.	intra-procedure
Secondary	Recurrence rate of aneurysms at 6 months	Recurrence is defined as increased contrast agent filling into the aneurysm sac at post-operative review compared to immediate post-procedure.	6 months±30 days post-procedure
Secondary	Retreatment rate	Retreatment is defined as during the study period any additional treatment of the target aneurysm after the original procedure.	180±30 days, 360±30 days post-procedure
Secondary	Operation satisfaction rate	The 5-point Likert scale is used to evaluate the operation satisfaction from three aspects: push performance, retracting performance and release performance. "Operation satisfaction rate" is defined as the proportion of investigational devices or comparators with Likert score=12 points.	intra-procedure
Secondary	Incidence of parent artery stenosis (>50%) in target area	Parent artery stenosis in target area is defined as stenosis degree >50%, which is diagnosed by postoperative cerebrovascular DSA at 6 months, CTA or MRA at 12 months.	180±30 days, 360±30 days post-procedure
Secondary	Incidence of parent artery occlusion in target area	Parent artery occlusion in target area is diagnosed by postoperative cerebrovascular DSA at 6 months, CTA or MRA at 12 months.	180±30 days, 360±30 days post-procedure
Secondary	Incidence of stroke	Stroke includes hemorrhagic stroke and symptomatic ischemic stroke.	30±7 days, 360±30 days post-procedure
Secondary	All-cause mortality	"All-cause mortality" is the proportion of subjects who die due to any cause.	30±7 days, 360±30 days post-procedure
Secondary	Incidence of adverse events	"Incidence of adverse events" is the proportion of subjects with adverse events using the investigational device or the comparator.	180±30 days, 360±30 days post-procedure
Secondary	Incidence of serious adverse events	"Incidence of serious adverse events" is the proportion of subjects with serious adverse events using the investigational device or the comparator.	180±30 days, 360±30 days post-procedure
Secondary	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.	intra-procedure, 180±30 days post-procedure