A Prospective, Multicenter, Single Arm Clinical Trial to Evaluate the Safety and Effectiveness of Flow Modulation Device for Intracranial Aneurysms

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to assess safety and effectiveness of the p64/p48 MW HPC Flow Modulation Device.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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 target aneurysm is planned to be embolized using flow modulation devices only;

• The mRS Score of the patients was 0-2

• Patients understand the purpose of the study, accept the follow-up period, and agree to comply with all requirements, agree to participate in the clinical trial and voluntarily sign the informed consent.

Locations
Other Locations
China
Xuanwu Hospital, Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Wenwen Jia
Wendy.Jia@wallabyphenox.com
+86 18818201005
Time Frame
Start Date: 2023-11-17
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 120
Treatments
Experimental: Test group
Patients can be included in the study if they meet all of the inclusion and none of the exclusion criteria and have provided written informed consent, intent to use Flow modulation device to treat intracranial aneurysm.
Related Therapeutic Areas
Sponsors
Collaborators: Phenox GmbH, Beijing Wallaby Medical Technologies Co.,Inc.
Leads: Shanghai Wallaby Medical Technologies Co.,Inc.

This content was sourced from clinicaltrials.gov