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

Intracranial Aneurysm Clinical Trial

— SAFETI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05524285
• Other study ID #: Study 2022-0505
• Status: Recruiting
• Phase: N/A
• Start date: February 2023
• Est. completion date: March 2024

Study information

• Verified date: August 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Jing Xu
• Phone: 13958119687
• Email: jingxu[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: March 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• Intracranial Support Catheter
Endovascular procedure using the intracranial support catheter which approved by NMPA
• Guide Catheter
Endovascular procedure using the guide catheter which approved by NMPA

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	Huzhou Central Hospital	Huzhou	Zhejiang
China	Lishui Municipal Central Hospital	Lishui	Zhejiang
China	Lishui People's Hospital	Lishui	Zhejiang
China	Ningbo First Hospital	Ningbo	Zhejiang
China	Ningbo Medical Center Lihuili Hospital	Ningbo	Zhejiang
China	Shaoxing People's Hospital	Shaoxing	Zhejiang
China	Taizhou Hospital of Zhejiang Province	Taizhou	Zhejiang
China	The Second Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of new-onset DWI positive postoperation	New-onset DWI positive is defined as any new hyperintense lesions.	within 48 hours postoperation
Secondary	Rate of catheter-related complications	Catheter-related complications are defined as vasospasm, vascular dissection, etc. which caused by catheter during operation.	Intraoperation
Secondary	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
Secondary	Rate of mRS score 0-2 at 90 days	mRS score 0-2 indicates good prognosis.	90±14 days postoperation
Secondary	All-cause mortality within 90 days	All-cause mortality is defined as all deaths due to any cause.	up to 90 days
Secondary	Incidence of Adverse Events (AE)		up to 90 days
Secondary	Incidence of Serious Adverse Events (SAE)		up to 90 days