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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
116
Cerebral arteriovenous malformation embolism
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGNan Fang Hospital
Guangzhou, Guangdong, China
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.
Time frame: Immediately after surgery
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 .
Time frame: 1,6,12months after surgery
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
Time frame: Immediately after surgery
Catheter performance evaluation
1. The ability of the catheter to reach the lesion . 2. The catheter has broken at the tip and perforated. 3. Intravascular complications associated with catheters occurred. 4. Degree of difficulty in tube withdrawal 5. Catheter jam
Time frame: Immediately after surgery
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Guangdong Provincial People's Hospital
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NOT_YET_RECRUITING...and 3 more locations