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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Device: Intracranial Support Catheter; Device: Guide Catheter

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.

• Study Type: Interventional
• Enrollment (Anticipated): 264
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jing Xu; Phone Number: 13958119687; Email: jingxu@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Second Affiliated Hospital, School of Medicine, Zhejiang University
      • Principal Investigator: Jing Xu
    • Huzhou, Zhejiang, China
      • Not yet recruiting
      • Huzhou Central Hospital
      • Principal Investigator: Sheng Qiu
    • Lishui, Zhejiang, China
      • Not yet recruiting
      • Lishui Municipal Central Hospital
      • Principal Investigator: Shike He
    • Lishui, Zhejiang, China
      • Not yet recruiting
      • Lishui People's Hospital
      • Principal Investigator: Huguang Li
    • Ningbo, Zhejiang, China
      • Not yet recruiting
      • Ningbo medical center lihuili hospital
      • Principal Investigator: Maosong Chen
    • Ningbo, Zhejiang, China
      • Not yet recruiting
      • Ningbo First Hospital
    • Shaoxing, Zhejiang, China
      • Not yet recruiting
      • Shaoxing People's Hospital
      • Principal Investigator: Xuebin Yu
    • Taizhou, Zhejiang, China
      • Not yet recruiting
      • Taizhou Hospital of Zhejiang Province
      • Principal Investigator: Shanping Ruan
    • Wenzhou, Zhejiang, China
      • Not yet recruiting
      • The Second Affiliated Hospital of Wenzhou Medical University
      • Principal Investigator: Bo Yin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: experimental group; Intracranial Support Catheter	Device: Intracranial Support Catheter; Endovascular procedure using the intracranial support catheter which approved by NMPA
ACTIVE_COMPARATOR: control group; Guide Catheter	Device: Guide Catheter; Endovascular procedure using the guide catheter which approved by NMPA

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Jing Xu, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2023
• Primary Completion (ANTICIPATED): October 1, 2023
• Study Completion (ANTICIPATED): March 1, 2024

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (ACTUAL): September 1, 2022

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: Study 2022-0505

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No