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

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ClinicalTrials.gov Identifier: NCT05058482
Recruitment Status : Not yet recruiting
First Posted : September 27, 2021
Last Update Posted : September 27, 2021
Sponsor:
Information provided by (Responsible Party):
Suzhou Hengruihongyuan Medical Technology Co. LTD

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.

Condition or disease Intervention/treatment Phase
Intracranial Arteriovenous Malformations Device: embolism Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-center, Randomized Parallel Controlled Study on the Safety and Effectiveness of the Non-adhesive Liquid Embolic System in the Embolization of Cerebral Arteriovenous Malformations
Estimated Study Start Date : October 17, 2021
Estimated Primary Completion Date : October 17, 2023
Estimated Study Completion Date : October 17, 2024


Arm Intervention/treatment
Experimental: Non-adhesive Liquid Embolic System(NALES) Device: embolism
Cerebral arteriovenous malformation embolism

Active Comparator: Onyx Liquid Embolic System& Marathon Flow Directed Micro Catheter Device: embolism
Cerebral arteriovenous malformation embolism




Primary Outcome Measures :
  1. Effective embolization rate of malformed masses [ Time Frame: 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 Outcome Measures :
  1. MRS score [ Time Frame: 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 .

  2. Technical success rate [ Time Frame: 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

  3. Catheter performance evaluation [ Time Frame: 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 Outcome Measures:
  1. Incidence of major adverse events related to device or surgical procedures within 1 month after surgery [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05058482


Contacts
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Contact: Jianmin Liu, Doctor 13901780638 liu118@vip.163.com

Locations
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China, Guangdong
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510280
Contact: Chuanzhi Duan         
Nan Fang Hospital
Guangzhou, Guangdong, China, 510515
Contact: Songtao Qi         
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Contact: Dong Zhou         
China, Heilongjiang
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Contact: Huaizhang Shi         
China, Henan
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Contact: Tianxiao Li         
China, Hubei
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430071
Contact: Jincao Chen         
China, Jiangsu
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
Contact: Ya Peng         
Nanjng Drum Tower Hospital
Nanjing, Jiangsu, China, 210008
Contact: Chunhua Hang         
General Hospital of Eastern Theater Command
Nanjing, Jiangsu, China
Contact: HanDong Wang         
China, Jiangxi
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Contact: Xingen Zhu         
China, Shanghai
Huashan Hospital ,Fudan University
Shanghai, Shanghai, China
Contact: Yuxiang Gu, Doctor         
Shanghai Changhai Hospital
Shanghai, Shanghai, China
Contact: Jianmin Liu, Doctor         
China, Zhejiang
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 322000
Contact: Jianmin Zhang         
Sponsors and Collaborators
Suzhou Hengruihongyuan Medical Technology Co. LTD
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Responsible Party: Suzhou Hengruihongyuan Medical Technology Co. LTD
ClinicalTrials.gov Identifier: NCT05058482    
Other Study ID Numbers: Nal01
First Posted: September 27, 2021    Key Record Dates
Last Update Posted: September 27, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Suzhou Hengruihongyuan Medical Technology Co. LTD:
Non-adhesive Liquid Embolic System
Additional relevant MeSH terms:
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Hemangioma
Intracranial Arteriovenous Malformations
Arteriovenous Malformations
Congenital Abnormalities
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Vascular Malformations
Nervous System Malformations
Intracranial Arterial Diseases