A Prospective, Multicenter,Single Arm Clinical Investigation Evaluating Safety and Effectiveness of the Flow Diverter for Treating Patients With Intracranial Aneurysms

Date de début de l'étude : 17 octobre 2021

Inclusion Criteria: ●≥18 years old and ≤75 years old, male or unpregnant female * Untreated and unruptured intracranial wide-necked aneurysm confirmed by preoperative imaging diagnosis (wide-necked aneurysm was defined as the tumor neck ≥4mm or the tumor body/tumor neck ratio \<2) * The target aneurysm is planned to be treated with blood flow guidance device only, without the need to complete the treatment by stages * The width of tumor neck should be less than 30mm * Imaging measurements of the tumor parent artery showed that the diameter was 1.5mm \~ 6.5mm * The subject or legal guardian can understand the purpose of the study, demonstrate sufficient compliance with the study protocol, and sign the informed consent Exclusion Criteria: * The target aneurysm has previously received craniotomy clipping or other endovascular interventional treatment * Target aneurysms were haemacular aneurysms, pseudoaneurysms, arteriovenous malformations and moyamoya disease related aneurysms * DSA suggested vascular path tortuosity or severe arteriosclerosis, and it was difficult for the instrument to reach the target vessel * Contraindications to dual antiplatelet therapy and anticoagulation therapy * Patients with known clear allergy to nickel-titanium alloys and platinum-tungsten alloys * People with known severe allergy to contrast media (excluding rash) * patients with known dementia or mental illness * Preoperative complicated with serious heart, liver, kidney, respiratory system diseases and bleeding disorders * Life expectancy is less than one year * Is participating in, or may participate in, any other drug or medical device clinical trial after inclusion in this clinical trial * Other conditions determined by the investigator to be unsuitable for participation in this clinical trial