Actively Recruiting
To Evaluate the Safety and Effectiveness of Flow Modulation Device for Intracranial Aneurysms
Led by Shanghai Wallaby Medical Technologies Co.,Inc. · Updated on 2024-06-27
120
Participants Needed
1
Research Sites
136 weeks
Total Duration
On this page
Sponsors
S
Shanghai Wallaby Medical Technologies Co.,Inc.
Lead Sponsor
P
Phenox GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to assess safety and effectiveness of the p64/p48 MW HPC Flow Modulation Device.
CONDITIONS
Official Title
To Evaluate the Safety and Effectiveness of Flow Modulation Device for Intracranial Aneurysms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged from 18 to 80 years, male or female
- Diagnosed with intracranial aneurysms by brain CTA, MRA, or DSA
- Have unruptured saccular or fusiform aneurysms planned for treatment with a flow modulation device
- Target aneurysm parent vessel diameter between 1.75 and 5 mm
- Planned embolization using only flow modulation devices
- Modified Rankin Scale (mRS) score of 0 to 2
- Understand the study purpose, accept follow-up, agree to comply with study requirements, and sign informed consent
You will not qualify if you...
- Contraindications to antiplatelet or anticoagulant therapy or failure to start antiplatelet therapy before treatment
- Anatomical unsuitability for endovascular treatment due to severe vascular tortuosity or stenosis
- Acute ruptured aneurysm or history of intracranial hemorrhage or subarachnoid hemorrhage within 30 days before surgery
- Previous endovascular treatment of target aneurysm before enrollment
- Allergy to Nitinol platinum alloy or angiographic agents
- Conditions preventing study completion, such as expected survival less than 1 year, high risk of cerebral thrombosis, heart failure, or atrial fibrillation
- Target aneurysms that are blood vesicular aneurysms, pseudoaneurysms, or associated with arteriovenous malformation, moyamoya disease, or multiple aneurysms not treatable by a single device
- Uncontrolled serious infection
- Major surgery or interventional therapy within 30 days before surgery
- Abnormal coagulation function or bleeding tendency
- Severe renal insufficiency with creatinine ≥ 200 umol/L; severe liver disease or ALT more than 3 times the upper normal limit
- Pregnancy, lactation, or planning pregnancy during the study
- Participation in another clinical trial within 30 days before consent
- Other conditions deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Xuanwu Hospital, Capital Medical University
Beijing, China
Actively Recruiting
Research Team
W
Wenwen Jia
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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