Back to resultsSafety Study of Intracranial Support Catheter and Guide Catheter for Stent-Assisted Embolization in the Treatment of Intracranial Aneurysms (SAFETI)
Primary Purpose
Intracranial Aneurysm
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intracranial Support Catheter
Guide Catheter
Sponsored by
About this trial
This is an interventional treatment trial for Intracranial Aneurysm
Eligibility Criteria
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.
Sites / Locations
- Second Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting
- Huzhou Central Hospital
- Lishui Municipal Central Hospital
- Lishui People's Hospital
- Ningbo First Hospital
- Ningbo Medical Center Lihuili Hospital
- Shaoxing People's Hospital
- Taizhou Hospital of Zhejiang Province
- The Second Affiliated Hospital of Wenzhou Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
experimental group
control group
Arm Description
Intracranial Support Catheter
Guide Catheter
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Incidence of new-onset DWI positive postoperation
New-onset DWI positive is defined as any new hyperintense lesions.
Rate of catheter-related complications
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
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
mRS score 0-2 indicates good prognosis.
All-cause mortality within 90 days
All-cause mortality is defined as all deaths due to any cause.
Incidence of Adverse Events (AE)
Incidence of Serious Adverse Events (SAE)
Full Information
NCT ID
NCT05524285
First Posted
August 30, 2022
Last Updated
February 7, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT05524285
Brief Title
Safety Study of Intracranial Support Catheter and Guide Catheter for Stent-Assisted Embolization in the Treatment of Intracranial Aneurysms
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
264 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
Intracranial Support Catheter
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Guide Catheter
Intervention Type
Device
Intervention Name(s)
Intracranial Support Catheter
Intervention Description
Endovascular procedure using the intracranial support catheter which approved by NMPA
Intervention Type
Device
Intervention Name(s)
Guide Catheter
Intervention Description
Endovascular procedure using the guide catheter which approved by NMPA
Primary Outcome Measure Information:
Title
Incidence of symptomatic cerebral infarction within 48 hours postoperation
Description
Symptomatic cerebral infarction is defined as NIHSS score increased by≥4 points compared with preoperation, along with imaging confirmed to be caused by infarction.
Time Frame
within 48 hours postoperation
Secondary Outcome Measure Information:
Title
Incidence of new-onset DWI positive postoperation
Description
New-onset DWI positive is defined as any new hyperintense lesions.
Time Frame
within 48 hours postoperation
Title
Rate of catheter-related complications
Description
Catheter-related complications are defined as vasospasm, vascular dissection, etc. which caused by catheter during operation.
Time Frame
Intraoperation
Title
Incidence of symptomatic cerebral infarction at 7 days postoperation or at discharge
Description
Symptomatic cerebral infarction is defined as NIHSS score increased by≥4 points compared with preoperation, along with imaging confirmed to be caused by infarction.
Time Frame
7 days postoperation or discharged
Title
Rate of mRS score 0-2 at 90 days
Description
mRS score 0-2 indicates good prognosis.
Time Frame
90±14 days postoperation
Title
All-cause mortality within 90 days
Description
All-cause mortality is defined as all deaths due to any cause.
Time Frame
up to 90 days
Title
Incidence of Adverse Events (AE)
Time Frame
up to 90 days
Title
Incidence of Serious Adverse Events (SAE)
Time Frame
up to 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Xu
Phone
13958119687
Email
jingxu@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Xu
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Second Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Xu
Facility Name
Huzhou Central Hospital
City
Huzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheng Qiu
Facility Name
Lishui Municipal Central Hospital
City
Lishui
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shike He
Facility Name
Lishui People's Hospital
City
Lishui
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huguang Li
Facility Name
Ningbo First Hospital
City
Ningbo
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiqing Lin
Facility Name
Ningbo Medical Center Lihuili Hospital
City
Ningbo
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maosong Chen
Facility Name
Shaoxing People's Hospital
City
Shaoxing
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuebin Yu
Facility Name
Taizhou Hospital of Zhejiang Province
City
Taizhou
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shanping Ruan
Facility Name
The Second Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Yin
12. IPD Sharing Statement
Learn more about this trial
Safety Study of Intracranial Support Catheter and Guide Catheter for Stent-Assisted Embolization in the Treatment of Intracranial Aneurysms
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