Status:
COMPLETED
Efficacy and Safety of the Flow Diverter (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms
Lead Sponsor:
Ton-Bridge Medical Tech. Co., Ltd
Conditions:
Intracranial Aneurysm
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this study is to assess the efficacy and safety of the Flow Diverter (Tonbridge) for endovascular treatment of intracranial aneurysms.
Detailed Description
This is a prospective, multi-center, randomized, open, positive-controlled, non-inferiority trial. This clinical trial is conducted at more than 5 centers in China. Eligible patients are randomized in...
Eligibility Criteria
Inclusion
- Age 18 to 80 years, any gender;
- Unruptured intracranial aneurysms locate in the internal carotid artery (ICA) or vertebral artery (VA) with a neck ≥ 4 mm and a maximal diameter ≥ 10 mm, which 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
- Diagnosed as multiple aneurysms which cannot be covered by a single stent or with cerebrovascular malformations;
- Subarachnoid hemorrhage of the target aneurysm within 30 days pre-procedure;
- Modified Rankin Scale (mRS) score \> 2 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 brain tumor, systemic infection, disseminated intravascular coagulation, myocardial infarction within 12 months before enrollment, history of severe psychosis);
- The lesion which 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, 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.
Key Trial Info
Start Date :
August 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2023
Estimated Enrollment :
187 Patients enrolled
Trial Details
Trial ID
NCT04799964
Start Date
August 12 2021
End Date
September 22 2023
Last Update
September 19 2024
Active Locations (13)
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1
The First Affiliated Hospital of USTC
Hefei, Anhui, China
2
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, China
3
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
4
Nanyang Central Hospital
Nanyang, Henan, China