An interventional study of Intracranial Support Catheter and Guide Catheter in Intracranial Aneurysm, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 9 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-02-09.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment
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.
427 studies on the registry are indexed under Intracranial Aneurysm; 115 are open to participants now.
This study's planned enrollment of 264 is above the median of 110 across 207 interventional studies indexed under Intracranial Aneurysm.
Browse Intracranial Aneurysm studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intracranial Support Catheter
Device: Intracranial Support Catheter
Guide Catheter
Device: Guide Catheter
Endovascular procedure using the intracranial support catheter which approved by NMPA
Endovascular procedure using the guide catheter which approved by NMPA
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)
Time frame: up to 90 days
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, School of Medicine, Zhejiang University