Prospective, Multicenter, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of pEGASUS Stent System for Assisted Endovascular Treatment of 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 pEGASUS stent system.
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 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;
• 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
Changhai Hospital
RECRUITING
Shanghai
Contact Information
Primary
Wenwen Jia
wendy.jia@wallabyphenox.com
+86 18818201005
Time Frame
Start Date: 2023-12-29
Estimated Completion Date: 2026-06-20
Participants
Target number of participants: 130
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 pEGASUS stent system assisted to treat intracranial aneurysm.
Related Therapeutic Areas
Sponsors
Collaborators: Phenox GmbH, Beijing Wallaby Medical Technologies Co.,Inc.
Leads: Shanghai Wallaby Medical Technologies Co.,Inc.