Clinical trial NCT04918420: A Single-arm Trial of the Flow Diverter (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms
Official title: Efficacy and Safety of the Flow Diverter (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms: a Prospective, Multi-center, Single-arm Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Intracranial Aneurysm
Lead sponsor: Ton-Bridge Medical Tech. Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-06-08
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Complete occlusion rate of aneurysms at 12 months
timeFrame: 360±30 days post-procedure
Secondary outcomes:
measure: Immediate procedural success rate
timeFrame: intra-procedure
measure: Complete occlusion rate of aneurysms at 6 months
timeFrame: 180±30 days post-procedure
measure: Successful occlusion rate of aneurysms at 12 months
timeFrame: 360±30 days post-procedure
measure: Incidence of new-onset stroke in the territory supplied by the treated artery or neurologic death at 12 months
timeFrame: 360±30 days post-procedure
measure: Incidence of technical complications
timeFrame: intra-procedure
measure: Incidence of any stroke
timeFrame: 30±7 days, 360±30 days post-procedure
measure: Incidence of parent artery stenosis ( > 50%）in target area at 12 months
timeFrame: 360±30 days post-procedure
measure: Incidence of parent artery occlusion in target area at 12 months
timeFrame: 360±30 days post-procedure
measure: Incidence of adverse events
timeFrame: pre-procedure, intra-procedure, within 24 hours, 30±7 days, 90±14 days, 180±30 days, 360±30 days post-procedure
measure: Incidence of serious adverse events
timeFrame: pre-procedure, intra-procedure, within 24 hours, 30±7 days, 90±14 days, 180±30 days, 360±30 days post-procedure
measure: Mortality rate
timeFrame: 30±7 days, 360±30 days post-procedure
measure: Operation satisfaction rate
timeFrame: intra-procedure
measure: Incidence of device deficiency
timeFrame: intra-procedure, 360±30 days post-procedure
Other outcomes:
Locations:
city: Wuhu
country: China
facility: The First Affiliated Hospital of Wannan Medical College
state: Anhui
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Hangzhou
country: China
facility: Zhejiang Hospital
state: Zhejiang
city: Chongqing
country: China
facility: Xinqiao Hospital, Army Medical University
city: Shanghai
country: China
facility: Changhai Hospital of Shanghai
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
Study officials:
affiliation: Changhai Hospital
name: Jianmin Liu
role: PRINCIPAL_INVESTIGATOR
References: