Non-adhesive Liquid Embolic System in the Embolization of Cerebral Arteriovenous Malformations
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
1 other identifier
interventional
116
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2021
Typical duration for not_applicable
13 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
September 24, 2021
CompletedFirst Posted
Study publicly available on registry
September 27, 2021
CompletedStudy Start
First participant enrolled
December 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 17, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 17, 2024
CompletedMay 6, 2022
September 1, 2021
1.9 years
September 24, 2021
May 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Immediately after surgery
Secondary Outcomes (3)
MRS score
1,6,12months after surgery
Technical success rate
Immediately after surgery
Catheter performance evaluation
Immediately after surgery
Other Outcomes (1)
Incidence of major adverse events related to device or surgical procedures within 1 month after surgery
1 month after surgery
Study Arms (2)
Non-adhesive Liquid Embolic System(NALES)
EXPERIMENTALOnyx Liquid Embolic System& Marathon Flow Directed Micro Catheter
ACTIVE COMPARATORInterventions
Cerebral arteriovenous malformation embolism
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280, China
Nan Fang Hospital
Guangzhou, Guangdong, 510515, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
Nanjng Drum Tower Hospital
Nanjing, Jiangsu, 210008, China
General Hospital of Eastern Theater Command
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Huashan Hospital ,Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 322000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2021
First Posted
September 27, 2021
Study Start
December 2, 2021
Primary Completion
October 17, 2023
Study Completion
October 17, 2024
Last Updated
May 6, 2022
Record last verified: 2021-09