Safety Study of Intracranial Support Catheter and Guide Catheter for Stent-Assisted Embolization in the Treatment of Intracranial Aneurysms
SAFETI
1 other identifier
interventional
264
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2023
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2022
CompletedFirst Posted
Study publicly available on registry
September 1, 2022
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedFebruary 9, 2023
August 1, 2022
8 months
August 30, 2022
February 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Incidence of new-onset DWI positive postoperation
within 48 hours postoperation
Rate of catheter-related complications
Intraoperation
Incidence of symptomatic cerebral infarction at 7 days postoperation or at discharge
7 days postoperation or discharged
Rate of mRS score 0-2 at 90 days
90±14 days postoperation
All-cause mortality within 90 days
up to 90 days
- +2 more secondary outcomes
Study Arms (2)
experimental group
EXPERIMENTALIntracranial Support Catheter
control group
ACTIVE COMPARATORGuide Catheter
Interventions
Endovascular procedure using the intracranial support catheter which approved by NMPA
Endovascular procedure using the guide catheter which approved by NMPA
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
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, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jing Xu
Second Affiliated Hospital, School of Medicine, Zhejiang University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2022
First Posted
September 1, 2022
Study Start
February 1, 2023
Primary Completion
October 1, 2023
Study Completion
March 1, 2024
Last Updated
February 9, 2023
Record last verified: 2022-08