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

Zhejiang University

Status: Enrolling

Conditions: Intracranial Aneurysm

Treatments: Device: Intracranial Support Catheter; Device: Guide Catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT05524285

Study 2022-0505

Details and patient eligibility

About

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.

Full 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.

Enrollment: 264 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

264 participants in 2 patient groups

experimental group

Experimental group

Description:

Intracranial Support Catheter

Treatment:

Device: Intracranial Support Catheter

control group

Active Comparator group

Description:

Guide Catheter

Treatment:

Device: Guide Catheter