The purpose of this study is to assess safety and effectiveness of the p64/p48 MW HPC Flow Modulation Device.
Title: A prospective, multicenter, single arm clinical trial to evaluate the safety and effectiveness of Flow Modulation Device for intracranial aneurysms. Device: p64/p48 MW HPC Flow Modulation Device. Study design: Prospective, multicenter, single arm Clinical Study. Purpose: To assess safety and effectiveness of p64/p48 MW HPC Flow Modulation Device . Study duration: 32 months. Sample Size: 120 patients. Number of sites: ≤10. Follow-up time: 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Endovascular intervention with p64/p48 MW HPC Flow Modulation Device was performed in patients diagnosed with intracranial aneurysms
Xuanwu Hospital, Capital Medical University
Beijing, China
RECRUITINGRate of complete occlusion
Raymond grade was evaluated by the independent imaging evaluation Committee 12 months after surgery according to the subjects' imaging results, and the rate of complete aneurysm occlusion was calculated. Aneurysm complete occlusion is defined as Raymond Grade I.
Time frame: 12 months
Technical success rate
Technical success is defined as the successful placement of a Flow Modulation Device. Successful implantation means that the Flow Modulation Device is placed at the target site and effectively covers the neck of the aneurysm, and the rest of the device is successfully released and withdrawn to the outside of the body.
Time frame: Within 24 hours after surgery
Rate of successful occlusion
Raymond grade was evaluated by the independent imaging evaluation Committee 6 months and 12 months after surgery according to the subjects' imaging results, and the rate of successful aneurysm occlusion was calculated. Aneurysm successful occlusion is defined as Raymond Grade I/II.
Time frame: 6 months, 12 months
Rate of complete occlusion
Raymond grade was evaluated by the independent imaging evaluation Committee 6 months after surgery according to the subjects' imaging results, and the rate of complete aneurysm occlusion was calculated. Aneurysm complete occlusion is defined as Raymond Grade I.
Time frame: 6 months
Rate of good clinical prognosis
Good clinical prognosis means mRS 0\~2
Time frame: 3 months, 6 months, 12 months
Rate of in-stent-stenosis
In-stent-stenosis defined as moderate or severe stenosis of the tumor artery, that is, stenosis \> 50%
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: to 6 months, to 12 months
Device performance evaluation
After each use of the device, the researchers evaluated the operational performance of the device in terms of conveying, flexibility, compliance and wall adhesion.
Time frame: Within 24 hours after surgery
Death, stroke, and thrombotic events
Record the number of death, stroke and thrombotic events throughout the clinical trial period.
Time frame: to 12 months