The purpose of this study is to assess safety and effectiveness of the pEGASUS stent system.
Title: A prospective, multicenter, single-arm clinical trial to evaluate the safety and efficacy of pEGASUS stent system for assisted endovascular treatment of intracranial aneurysms Device: pEGASUS stent system Design: Prospective, Multicenter, Single Arm Clinical Study. Purpose: To assess safety and effectiveness of the pEGASUS stent system. Study duration: 31 months. Sample Size: 130 patients. Number of sites: ≤10. Follow-up time: 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Endovascular intervention with p64/p48 MW HPC pEGASUS Stent System was performed in patients diagnosed with intracranial aneurysms
Changhai Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGAneurysm Occlusion of the Treated Target Lesion on 6 Month Angiography
Complete aneurysm occlusion (100% occlusion - Raymond Class 1) of the treated target lesion on 6 month angiography, in the absence of retreatment, or parent artery stenosis (\> 50%) at the target location.
Time frame: 6 months
Rate of major ipsilateral stroke or neurological death
Any major ipsilateral stroke or neurological death
Time frame: 12 months
Technical success rate
Technical success is defined as the successful placement of pEGASUS stent system.
Time frame: Within 24 hours after surgery
Rate of successful occlusion
Aneurysm successful occlusion is defined as Raymond Grade I/II.
Time frame: Within 24 hours after surgery, 6 months, 12 months
Rate of complete occlusion
Aneurysm complete occlusion is defined as Raymond Grade I.
Time frame: Within 24 hours after surgery, 6 months, 12 months
Rate of good clinical prognosis
Good clinical prognosis means mRS 0\~2
Time frame: 3 months, 6 months, 12 months
Death, stroke, and thrombotic events
Record the number of death, stroke and thrombotic events throughout the clinical trial period.
Time frame: to 12 months
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