Clinical trial NCT05058482: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Intracranial Arteriovenous Malformations
Keywords: Non-adhesive Liquid Embolic System
Lead sponsor: Suzhou Hengruihongyuan Medical Technology Co. LTD
Sponsor class: INDUSTRY
First posted: 2021-09-27
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Age 18-70 years old, no gender limit.
2. The patient was diagnosed as cerebral arteriovenous malformation .
3. The patient had no history of bAVM treatment, including intervention, surgery or radiotherapy .
4. Spetzler Martin, grade I-IV .
5. The patient voluntarily signed the informed consent.

Exclusion Criteria:

1. History of heparin allergy.
2. The patient is allergic to contrast media.
3. 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).
4. Patient has irreversible coagulopathy (INR \> 1.5).
5. Intracranial hemorrhage 1 week before treatment.
6. MRS ≥4 due to neurological dysfunction.
7. Patients with planned malformation resection after embolization.
8. Blood flow related aneurysms of supplying artery that need to be treated by other methods.
9. Complicated with severe cerebral artery stenosis.
10. Brain tumors that require recent surgery.
11. Complicated with proliferative cerebrovascular disease.
12. Pregnant or lactating women.
13. Participants who have participated in other clinical trials within the last 3 months and failed to reach the end point.
14. The number of embolism is expected to be greater than or equal to 4 times during the study period (within 1 year).
15. Subjects deemed unsuitable for this study by the investigator.

Primary outcomes:
measure: Effective embolization rate of malformed masses
timeFrame: Immediately after surgery
Secondary outcomes:
measure: MRS score
timeFrame: 1,6,12months after surgery
measure: Technical success rate
timeFrame: Immediately after surgery
measure: Catheter performance evaluation
timeFrame: Immediately after surgery
Other outcomes:
measure: Incidence of major adverse events related to device or surgical procedures within 1 month after surgery
timeFrame: 1 month after surgery
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Nan Fang Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Harbin
country: China
facility: The First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Changzhou
country: China
facility: The First People's Hospital of Changzhou
state: Jiangsu
city: Nanjing
country: China
facility: Nanjng Drum Tower Hospital
state: Jiangsu
city: Nanjing
country: China
facility: General Hospital of Eastern Theater Command
state: Jiangsu
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Shanghai
country: China
facility: Huashan Hospital ,Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
state: Shanghai
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: