The purpose of this study is to assess safety and effectiveness of the pEGASUS stent system.
Aged from 18 to 80 years, male or female;
Patients diagnosed as wide-neck intracranial aneurysms by brain CTA/MRA/DSA (neck width≥4mm or bodyor a dome-to-neck ratio<2);
Parent vessel with a diameter of ≥2.5mm and ≤4.5mm;
Patients target aneurysm is planned to be embolized using intracranial stent assisted with coiling;
Patients who have contraindications to antiplatelet and/or anticoagulant therapy or do not start antiplatelet therapy in time before treatment.
Patients with anatomical structure is not suitable for endovascular treatment due to severe vascular tortuosity or stenosis shown by angiography.
Known to be allergic to Nitinol platinum alloy and angiographic agents.
Conditions that in the opinion of the investigators would prevent patients from completing the study, such as the expected survival period of active tumor less than 1-year, high-risk group of cerebral thrombosis, heart failure and atrial fibrillation.
Single group
pEGASUS Stent System
DeviceEndovascular intervention with p64/p48 MW HPC pEGASUS Stent System was performed in patients diagnosed with intracranial aneurysms
Aneurysm Occlusion of the Treated Target Lesion on 6 Month Angiography
Complete aneurysm occlusion (100% occlusion - Raymond Class 1) of the treated target lesion on 6 month angiography, in the absence of retreatment, or parent artery stenosis (\> 50%) at the target location.
Rate of major ipsilateral stroke or neurological death
Any major ipsilateral stroke or neurological death
Technical success rate
Technical success is defined as the successful placement of pEGASUS stent system.
Rate of successful occlusion
Aneurysm successful occlusion is defined as Raymond Grade I/II.
Rate of complete occlusion
Aneurysm complete occlusion is defined as Raymond Grade I.
Rate of good clinical prognosis
Good clinical prognosis means mRS 0\~2
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Shanghai Wallaby Medical Technologies Co.,Inc.
Lead sponsor
Phenox GmbH
Collaborator
Beijing Wallaby Medical Technologies Co.,Inc.
Collaborator
