Intracranial Arteriovenous Malformations
Conditions
Keywords
Non-adhesive Liquid Embolic System
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.
Interventions
DEVICEembolism
Cerebral arteriovenous malformation embolism
Sponsors
Suzhou Hengruihongyuan Medical Technology Co. LTD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effective embolization rate of malformed masses | Immediately after surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| MRS score | 1,6,12months after surgery | 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 | Immediately after surgery | 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 | Immediately after surgery | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of major adverse events related to device or surgical procedures within 1 month after surgery | 1 month after surgery | 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. |
Countries
China
Contacts
Primary ContactJianmin Liu, Doctor
Outcome results
None listed