Safety Study of Intracranial Support Catheter and Guide Catheter for Stent-Assisted Embolization in the Treatment of Intracranial Aneurysms

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Safety Study of Intracranial Support Catheter and Guide Catheter for Stent-Assisted Embolization in the Treatment of Intracranial Aneurysms: A Prospective, Multicenter, Randomized, Open, Controlled, Superiority Trial

Conditions
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Intracranial Aneurysm

Intervention / Treatment
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* Device: Intracranial Support Catheter
* Device: Guide Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age≥18 and≤70 years, any gender; Preoperative modified Rankin Scale (mRS) score 0-2; Subject has an unruptured intracranial aneurysm in the anterior circulation diagnosed by DSA/CTA/MRA (accept the results from other hospital)； No intracranial hemorrhage and recent cerebral infarction (DWI indicates hyperintense lesions) are founded by preoperative MRI+DWI; Subject is assessed as suitable for stent-assisted coil embolization (SACE) treatment (except flow diverter stent); Subject or guardian is able to understand the purpose of study, shows sufficient compliance with the study protocol and provides a signed informed consent form. Exclusion Criteria: Inadequate antiplatelet therapy before surgery (more than 3 days); Subject with atrial fibrillation, patent foramen ovale, atrial septal defect, ventricular septal defect, and other diseases causing cardiogenic embolism; Inability to perform cranial MRI+DWI preoperatively and within 48 hours postoperatively; Hypertension that does not respond well to medical treatment (systolic blood pressure>185 mmHg and/or diastolic blood pressure>110 mmHg); Preoperative active bleeding or bleeding tendency (INR>3); Random blood glucose<2.7mmol/L or >22.2mmol/L; Heart, lung, liver and kidney failure or other serious diseases (intracranial tumor, intracranial arteriovenous malformation, severe infection, DIC, previous myocardial infarction, history of severe psychosis, etc.); Subject who will not cooperate or tolerate interventional operation; Anticipated life expectancy<1 year; Allergy, resistance or contraindication to one or more of the following: contrast agents, anesthetics, antiplatelet drugs, anticoagulants; Participated or participating in another drug or device clinical trial within 1 month prior to enrollment; Pregnant or breast-feeding woman; Other circumstances judged by researchers that are not suitable for enrollment; Catheter could not pass through due to obvious intracranial vessel stenosis or tortuosity determined from imaging; Multiple aneurysms and more than one aneurysm requiring treatment; The aneurysm body has arterial branches.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>Intracranial Support Catheter | Device: Intracranial Support Catheter<br>* Endovascular procedure using the intracranial support catheter which approved by NMPA<br>|
| Active Comparator: control group<br>Guide Catheter | Device: Guide Catheter<br>* Endovascular procedure using the guide catheter which approved by NMPA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | within 48 hours postoperation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of new-onset DWI positive postoperation | New-onset DWI positive is defined as any new hyperintense lesions. | 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. | 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. | 7 days postoperation or discharged | 
| Rate of mRS score 0-2 at 90 days | mRS score 0-2 indicates good prognosis. | 90±14 days postoperation | 
| All-cause mortality within 90 days | All-cause mortality is defined as all deaths due to any cause. | up to 90 days | 
| Incidence of Adverse Events (AE) |  | up to 90 days | 
| Incidence of Serious Adverse Events (SAE) |  | up to 90 days |