The purpose of this study is to evaluate the safety differences between intracranial support catheter and guide catheter for stent-assisted embolization in the treatment of unruptured intracranial aneurysms in the anterior circulation.
This is a prospective, multicenter, randomized, open, controlled, superiority trial carried out in 9 research centers over China. Patients are randomized 1:1 to therapy either intracranial support catheter or guide catheter. Taking the guide catheter as a control, to evaluate whether the safety of intracranial support catheter for stent-assisted embolization in the treatment of unruptured intracranial aneurysms in the anterior circulation is superior than that of the control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
264
Endovascular procedure using the intracranial support catheter which approved by NMPA
Endovascular procedure using the guide catheter which approved by NMPA
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGHuzhou Central Hospital
Huzhou, Zhejiang, China
NOT_YET_RECRUITINGLishui Municipal Central Hospital
Incidence of symptomatic cerebral infarction within 48 hours postoperation
Symptomatic cerebral infarction is defined as NIHSS score increased by≥4 points compared with preoperation, along with imaging confirmed to be caused by infarction.
Time frame: within 48 hours postoperation
Incidence of new-onset DWI positive postoperation
New-onset DWI positive is defined as any new hyperintense lesions.
Time frame: within 48 hours postoperation
Rate of catheter-related complications
Catheter-related complications are defined as vasospasm, vascular dissection, etc. which caused by catheter during operation.
Time frame: Intraoperation
Incidence of symptomatic cerebral infarction at 7 days postoperation or at discharge
Symptomatic cerebral infarction is defined as NIHSS score increased by≥4 points compared with preoperation, along with imaging confirmed to be caused by infarction.
Time frame: 7 days postoperation or discharged
Rate of mRS score 0-2 at 90 days
mRS score 0-2 indicates good prognosis.
Time frame: 90±14 days postoperation
All-cause mortality within 90 days
All-cause mortality is defined as all deaths due to any cause.
Time frame: up to 90 days
Incidence of Adverse Events (AE)
Time frame: up to 90 days
Incidence of Serious Adverse Events (SAE)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Lishui, Zhejiang, China
Lishui People's Hospital
Lishui, Zhejiang, China
NOT_YET_RECRUITINGNingbo First Hospital
Ningbo, Zhejiang, China
NOT_YET_RECRUITINGNingbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China
NOT_YET_RECRUITINGShaoxing People's Hospital
Shaoxing, Zhejiang, China
NOT_YET_RECRUITINGTaizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
NOT_YET_RECRUITINGTime frame: up to 90 days