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

Last updated: May 4, 2022
Sponsor: Suzhou Hengruihongyuan Medical Technology Co. LTD
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hemangioma

Abnormal Blood Vessels (Arteriovenous Malformations)

Holoprosencephaly

Treatment

N/A

Clinical Study ID

NCT05058482
Nal01
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 orradiotherapy .
  4. Spetzler Martin, grade I-IV .
  5. The patient voluntarily signed the informed consent.

Exclusion

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 ofnormal 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 othermethods.
  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 monthsand failed to reach the end point.
  14. The number of embolism is expected to be greater than or equal to 4 times during thestudy period (within 1 year).
  15. Subjects deemed unsuitable for this study by the investigator.

Study Design

Total Participants: 116
Study Start date:
December 02, 2021
Estimated Completion Date:
October 17, 2024

Study 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.

Connect with a study center

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong
    China

    Site Not Available

  • Nan Fang Hospital

    Guangzhou, Guangdong 510515
    China

    Site Not Available

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong 510280
    China

    Site Not Available

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang
    China

    Site Not Available

  • Henan Provincial People's Hospital

    Zhengzhou, Henan
    China

    Active - Recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei 430071
    China

    Site Not Available

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu
    China

    Site Not Available

  • General Hospital of Eastern Theater Command

    Nanjing, Jiangsu
    China

    Site Not Available

  • Nanjng Drum Tower Hospital

    Nanjing, Jiangsu 210008
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi
    China

    Site Not Available

  • Huashan Hospital ,Fudan University

    Shanghai, Shanghai
    China

    Site Not Available

  • Shanghai Changhai Hospital

    Shanghai, Shanghai
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang 322000
    China

    Site Not Available

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