The purpose of this study is to assess safety and effectiveness of the p64/p48 MW HPC Flow Modulation Device.
Aged from 18 to 80 years, male or female;
Patients diagnosed as intracranial aneurysms by brain CTA/MRA/DSA;
Patients with unruptured saccular aneurysms or fusiform aneurysm who are clinically determined to use flow modulation device for endovascular treatment;
The diameter of the target aneurysm parent vessel was 1.75-5mm;
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;
Patients with acute ruptured aneurysm or with a history of intracranial hemorrhage or subarachnoid hemorrhage within 30 days before surgery;
Patients with target aneurysm treated with endovascular interventional therapy before enrollment;
Single group
p64/p48 MW HPC Flow Modulation Device
DeviceEndovascular intervention with p64/p48 MW HPC Flow Modulation Device was performed in patients diagnosed with intracranial aneurysms
Rate of complete occlusion
Raymond grade was evaluated by the independent imaging evaluation Committee 12 months after surgery according to the subjects' imaging results, and the rate of complete aneurysm occlusion was calculated. Aneurysm complete occlusion is defined as Raymond Grade I.
Technical success rate
Technical success is defined as the successful placement of a Flow Modulation Device. Successful implantation means that the Flow Modulation Device is placed at the target site and effectively covers the neck of the aneurysm, and the rest of the device is successfully released and withdrawn to the outside of the body.
Rate of successful occlusion
Raymond grade was evaluated by the independent imaging evaluation Committee 6 months and 12 months after surgery according to the subjects' imaging results, and the rate of successful aneurysm occlusion was calculated. Aneurysm successful occlusion is defined as Raymond Grade I/II.
Rate of complete occlusion
Raymond grade was evaluated by the independent imaging evaluation Committee 6 months after surgery according to the subjects' imaging results, and the rate of complete aneurysm occlusion was calculated. 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
