Back to resultsNon-adhesive Liquid Embolic System in the Embolization of Cerebral Arteriovenous Malformations
Primary Purpose
Intracranial Arteriovenous Malformations
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
embolism
Sponsored by
About this trial
This is an interventional treatment trial for Intracranial Arteriovenous Malformations focused on measuring Non-adhesive Liquid Embolic System
Eligibility Criteria
Inclusion Criteria:
- Age 18-70 years old, no gender limit.
- The patient was diagnosed as cerebral arteriovenous malformation .
- The patient had no history of bAVM treatment, including intervention, surgery or radiotherapy .
- Spetzler Martin, grade I-IV .
- The patient voluntarily signed the informed consent.
Exclusion Criteria:
- History of heparin allergy.
- The patient is allergic to contrast media.
- Severe hepatic and renal insufficiency (serum creatinine ≥1.5 times the upper limit of normal value, alanine aminotransferase ≥3 times the upper limit of normal value, aspartate aminotransferase ≥3 times the upper limit of normal value).
- Patient has irreversible coagulopathy (INR > 1.5).
- Intracranial hemorrhage 1 week before treatment.
- MRS ≥4 due to neurological dysfunction.
- Patients with planned malformation resection after embolization.
- Blood flow related aneurysms of supplying artery that need to be treated by other methods.
- Complicated with severe cerebral artery stenosis.
- Brain tumors that require recent surgery.
- Complicated with proliferative cerebrovascular disease.
- Pregnant or lactating women.
- Participants who have participated in other clinical trials within the last 3 months and failed to reach the end point.
- The number of embolism is expected to be greater than or equal to 4 times during the study period (within 1 year).
- Subjects deemed unsuitable for this study by the investigator.
Sites / Locations
- Zhujiang Hospital of Southern Medical University
- Nan Fang Hospital
- Guangdong Provincial People's Hospital
- The First Affiliated Hospital of Harbin Medical University
- Henan Provincial People's HospitalRecruiting
- Zhongnan Hospital of Wuhan University
- The First People's Hospital of Changzhou
- Nanjng Drum Tower Hospital
- General Hospital of Eastern Theater Command
- The Second Affiliated Hospital of Nanchang University
- Huashan Hospital ,Fudan University
- Shanghai Changhai HospitalRecruiting
- The Second Affiliated Hospital of Zhejiang University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Non-adhesive Liquid Embolic System(NALES)
Onyx Liquid Embolic System& Marathon Flow Directed Micro Catheter
Arm Description
Outcomes
Primary Outcome Measures
Effective embolization rate of malformed masses
Number of effective embolization subjects / Total number of subjects x 100%.Definition of effective embolization : Postoperative DSA angiographic malformation volume decreased ≥50%. Volume of malformed groups = length × width × height /2.
Secondary Outcome Measures
MRS score
MRS refers to the modified Rankin scale, which is used to measure the neurological recovery of patients after stroke. It has a scale of zero to six. The higher the score, the worse the neurological function. MRS scores were collected at 1, 6 and 12 months after the operation before discharge .
Technical success rate
Success is represented by the ability to reach the lesion and embolize the malformed mass of the intended target, followed by successful catheter withdrawal from the body
Catheter performance evaluation
The ability of the catheter to reach the lesion .
The catheter has broken at the tip and perforated.
Intravascular complications associated with catheters occurred.
Degree of difficulty in tube withdrawal
Catheter jam
Full Information
NCT ID
NCT05058482
First Posted
September 24, 2021
Last Updated
May 4, 2022
Sponsor
Suzhou Hengruihongyuan Medical Technology Co. LTD
1. Study Identification
Unique Protocol Identification Number
NCT05058482
Brief Title
Non-adhesive Liquid Embolic System in the Embolization of Cerebral Arteriovenous Malformations
Official Title
A Prospective, Multi-center, Randomized Parallel Controlled Study on the Safety and Effectiveness of the Non-adhesive Liquid Embolic System in the Embolization of Cerebral Arteriovenous Malformations
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2021 (Actual)
Primary Completion Date
October 17, 2023 (Anticipated)
Study Completion Date
October 17, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Hengruihongyuan Medical Technology Co. LTD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This clinical trial is to verify the safety and effectiveness of the Non-adhesive Liquid Embolic System(NALES) produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. in the process of clinical use to support the application of the National Medical Products Administration ( NMPA) product registration approval.
Detailed Description
A prospective, multicenter, randomized controlled trial was used in this study. Onyx Liquid Embolic System and Marathon Flow Directed Micro Catheter, which were registered and marketed in China and had good effect in the industry, were selected as the control devices. Subjects requiring cerebral arteriovenous malformation embolization were selected to participate in the trial based on pathological conditions and inclusion/exclusion criteria, and the use of test products or control products was determined based on central randomized results. Imaging data involving the main evaluation criteria were evaluated uniformly by the blind evaluators of the leading unit, so as to reduce the bias caused by subjective factors of different evaluators.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Arteriovenous Malformations
Keywords
Non-adhesive Liquid Embolic System
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
116 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Non-adhesive Liquid Embolic System(NALES)
Arm Type
Experimental
Arm Title
Onyx Liquid Embolic System& Marathon Flow Directed Micro Catheter
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
embolism
Intervention Description
Cerebral arteriovenous malformation embolism
Primary Outcome Measure Information:
Title
Effective embolization rate of malformed masses
Description
Number of effective embolization subjects / Total number of subjects x 100%.Definition of effective embolization : Postoperative DSA angiographic malformation volume decreased ≥50%. Volume of malformed groups = length × width × height /2.
Time Frame
Immediately after surgery
Secondary Outcome Measure Information:
Title
MRS score
Description
MRS refers to the modified Rankin scale, which is used to measure the neurological recovery of patients after stroke. It has a scale of zero to six. The higher the score, the worse the neurological function. MRS scores were collected at 1, 6 and 12 months after the operation before discharge .
Time Frame
1,6,12months after surgery
Title
Technical success rate
Description
Success is represented by the ability to reach the lesion and embolize the malformed mass of the intended target, followed by successful catheter withdrawal from the body
Time Frame
Immediately after surgery
Title
Catheter performance evaluation
Description
The ability of the catheter to reach the lesion .
The catheter has broken at the tip and perforated.
Intravascular complications associated with catheters occurred.
Degree of difficulty in tube withdrawal
Catheter jam
Time Frame
Immediately after surgery
Other Pre-specified Outcome Measures:
Title
Incidence of major adverse events related to device or surgical procedures within 1 month after surgery
Description
Major adverse events related to instrumentation or surgical procedures within 1 month after surgery: bleeding during embolization, catheter indwelling, bleeding after embolization, symptomatic cerebral infarction, and edema.
Time Frame
1 month after surgery
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 18-70 years old, no gender limit.
The patient was diagnosed as cerebral arteriovenous malformation .
The patient had no history of bAVM treatment, including intervention, surgery or radiotherapy .
Spetzler Martin, grade I-IV .
The patient voluntarily signed the informed consent.
Exclusion Criteria:
History of heparin allergy.
The patient is allergic to contrast media.
Severe hepatic and renal insufficiency (serum creatinine ≥1.5 times the upper limit of normal value, alanine aminotransferase ≥3 times the upper limit of normal value, aspartate aminotransferase ≥3 times the upper limit of normal value).
Patient has irreversible coagulopathy (INR > 1.5).
Intracranial hemorrhage 1 week before treatment.
MRS ≥4 due to neurological dysfunction.
Patients with planned malformation resection after embolization.
Blood flow related aneurysms of supplying artery that need to be treated by other methods.
Complicated with severe cerebral artery stenosis.
Brain tumors that require recent surgery.
Complicated with proliferative cerebrovascular disease.
Pregnant or lactating women.
Participants who have participated in other clinical trials within the last 3 months and failed to reach the end point.
The number of embolism is expected to be greater than or equal to 4 times during the study period (within 1 year).
Subjects deemed unsuitable for this study by the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianmin Liu, Doctor
Phone
13901780638
Email
liu118@vip.163.com
Facility Information:
Facility Name
Zhujiang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510280
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chuanzhi Duan
Facility Name
Nan Fang Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Songtao Qi
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Zhou
Facility Name
The First Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huaizhang Shi
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tianxiao Li
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430071
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jincao Chen
Facility Name
The First People's Hospital of Changzhou
City
Changzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ya Peng
Facility Name
Nanjng Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunhua Hang
Facility Name
General Hospital of Eastern Theater Command
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HanDong Wang
Facility Name
The Second Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xingen Zhu
Facility Name
Huashan Hospital ,Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuxiang Gu, Doctor
Facility Name
Shanghai Changhai Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianmin Liu, Doctor
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
322000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianmin Zhang
12. IPD Sharing Statement
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Non-adhesive Liquid Embolic System in the Embolization of Cerebral Arteriovenous Malformations
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