Non-adhesive Liquid Embolic System in the Embolization of Cerebral Arteriovenous Malformations

Hengruihongyuan Medical Technology

Status: Enrolling

Conditions: Intracranial Arteriovenous Malformations

Treatments: Device: embolism

Study type: Interventional

Funder types: Industry

Identifiers

NCT05058482

Nal01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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116 participants in 2 patient groups

Non-adhesive Liquid Embolic System(NALES)

Experimental group

Treatment:

Device: embolism

Onyx Liquid Embolic System& Marathon Flow Directed Micro Catheter

Active Comparator group

Treatment:

Device: embolism