To Evaluate the Safety and Effectiveness of Flow Modulation Device for Intracranial Aneurysms

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Wallaby Medical Technologies Co.,Inc.

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

120 Participants
are divided into 1 treatment group

Sponsors and collaborators

Shanghai Wallaby Medical Technologies Co.,Inc.

Lead sponsor

Phenox GmbH

Collaborator

Beijing Wallaby Medical Technologies Co.,Inc.

Collaborator