Intracranial Aneurysm
Conditions
Brief summary
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
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.
Interventions
DEVICEIntracranial Support Catheter
Endovascular procedure using the intracranial support catheter which approved by NMPA
DEVICEGuide Catheter
Endovascular procedure using the guide catheter which approved by NMPA
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of symptomatic cerebral infarction within 48 hours postoperation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of catheter-related complications | Intraoperation | Catheter-related complications are defined as vasospasm, vascular dissection, etc. which caused by catheter during operation. |
| Incidence of symptomatic cerebral infarction at 7 days postoperation or at discharge | 7 days postoperation or discharged | Symptomatic cerebral infarction is defined as NIHSS score increased by≥4 points compared with preoperation, along with imaging confirmed to be caused by infarction. |
| Rate of mRS score 0-2 at 90 days | 90±14 days postoperation | mRS score 0-2 indicates good prognosis. |
| Incidence of new-onset DWI positive postoperation | within 48 hours postoperation | New-onset DWI positive is defined as any new hyperintense lesions. |
| Incidence of Adverse Events (AE) | up to 90 days | — |
| Incidence of Serious Adverse Events (SAE) | up to 90 days | — |
| All-cause mortality within 90 days | up to 90 days | All-cause mortality is defined as all deaths due to any cause. |
Countries
China
Contacts
Primary ContactJing Xu
Outcome results
None listed