About this trial
The purpose of this study is to assess safety and effectiveness of the p64/p48 MW HPC Flow Modulation Device.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- p64/p48 MW HPC Flow Modulation Device
Treatment groups
Sponsors and collaborators
Shanghai Wallaby Medical Technologies Co.,Inc.
Lead sponsor
Phenox GmbH
Collaborator
Beijing Wallaby Medical Technologies Co.,Inc.
Collaborator