Efficacy and Safety of the Flow Diverter (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms

Inclusion Criteria:

• Age 18 to 80 years, any gender;

• Unruptured intracranial aneurysms locate in the internal carotid artery (ICA) orvertebral artery (VA) with a neck ≥ 4 mm and a maximal diameter ≥ 10 mm, whichdiagnosed 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 sufficientcompliance with the study protocol and provides a signed informed consent form.

Exclusion Criteria:

• Diagnosed as multiple aneurysms which cannot be covered by a single stent or withcerebrovascular 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 NormalizedRatio (INR) > 1.5;

• Heart, lung, liver and renal failure or other severe diseases (such as brain tumor,systemic infection, disseminated intravascular coagulation, myocardial infarctionwithin 12 months before enrollment, history of severe psychosis);

• The lesion which is not appropriate for flow diverter delivery and deployment judgedby investigators (severe stenosis of parent artery, severe tortuosity of parentartery, stent failing to reach the lesion, etc.);

• Major surgery within 30 days before enrollment, or intending to receive surgerywithin 180 days after enrollment;

• Allergic history of anesthetics and contrast agents, or contraindication for dualantiplatelet 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 1month before signing informed consent;

• Other conditions judged by the investigators as unsuitable for enrollment.