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

  • STATUS
    Recruiting
  • End date
    Oct 17, 2024
  • participants needed
    116
  • sponsor
    Suzhou Hengruihongyuan Medical Technology Co. LTD
Updated on 14 May 2022

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.

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.

Details
Condition Intracranial Arteriovenous Malformations
Treatment embolism
Clinical Study IdentifierNCT05058482
SponsorSuzhou Hengruihongyuan Medical Technology Co. LTD
Last Modified on14 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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