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

Intracranial Aneurysm Clinical Trial

Official title:

Efficacy and Safety of the Flow Diverter (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms: A Prospective, Multi-center, Single-arm Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04918420
• Other study ID #: ZHTQ2021002
• Status: Recruiting
• Phase: N/A
• Start date: July 7, 2021
• Est. completion date: June 2027

Study information

• Verified date: September 2023
• Source: Zhuhai Tonbridge Medical Tech. Co., Ltd.
• Contact: Danqing Shen
• Phone: 15858207851
• Email: dq.shen[@]ton-bridge.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a prospective, multi-center, single-arm clinical trial carried out in 7 research centers over China. In this study, enrolled patients are treated with the Flow Diverter (Tonbridge) for intracranial aneurysms. The objective of this study is to evaluate the effectiveness and safety of the Flow Diverter (Tonbridge) for treatment of intracranial aneurysms.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: June 2027
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• Flow Diverter (Tonbridge)
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.

Locations

Country	Name	City	State
China	Xinqiao Hospital, Army Medical University	Chongqing
China	Zhejiang Hospital	Hangzhou	Zhejiang
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu
China	Changhai Hospital of Shanghai	Shanghai
China	Huashan Hospital Fudan University	Shanghai
China	The First Affiliated Hospital of Wannan Medical College	Wuhu	Anhui
China	Henan Provincial People's Hospital	Zhengzhou	Henan

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	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	Immediate procedural success rate	Intraoperative cerebrovascular DSA is performed to determine whether the investigational device positions exactly and covers the aneurysm neck effectively.	intra-procedure
Secondary	Complete occlusion rate of aneurysms at 6 months	Complete occlusion is defined as no contrast agent in the aneurysm (Raymond-Roy class I) which is diagnosed by MRA/CTA at 6 months post-procedure.	180±30 days post-procedure
Secondary	Successful occlusion rate of aneurysms at 12 months	Successful occlusion is defined as Raymond-Roy class I or II, which is diagnosed by DSA at 12 months post-procedure.	360±30 days post-procedure
Secondary	Incidence of new-onset stroke in the territory supplied by the treated artery or neurologic death at 12 months	New-onset stroke is defined as the occurrence of new stroke with an increase of = 4 points in the subjects' NIHSS score from preoperative baseline. Neurologic death is defined as death due to neurologic reasons directly.	360±30 days post-procedure
Secondary	Incidence of technical complications	Technical complications include but not limited to: stent incomplete opening, stent migration, stent herniation into the aneurysm sac, in-stent thrombosis, operation injury, etc.	intra-procedure
Secondary	Incidence of any stroke	Stroke includes hemorrhagic stroke and symptomatic ischemic stroke.	30±7 days, 360±30 days post-procedure
Secondary	Incidence of parent artery stenosis ( > 50%)in target area at 12 months	Parent artery stenosis in target area is defined as stenosis degree > 50%. Using postoperative cerebrovascular DSA at 12 months is performed to determine.	360±30 days post-procedure
Secondary	Incidence of parent artery occlusion in target area at 12 months	Postoperative cerebrovascular DSA at 12 months is performed to determine whether parent artery in target area is occluded.	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.	pre-procedure, intra-procedure, within 24 hours, 30±7 days, 90±14 days, 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.	pre-procedure, intra-procedure, within 24 hours, 30±7 days, 90±14 days, 180±30 days, 360±30 days post-procedure
Secondary	Mortality rate	Deaths due to any cause are calculated.	30±7 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 with Likert score = 12 points.	intra-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, malfunctions, etc.	intra-procedure, 360±30 days post-procedure