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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Intracranial Arteriovenous Malformations
• Intervention / Treatment: Device: embolism

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.

• Study Type: Interventional
• Enrollment (Anticipated): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Not yet recruiting
      • Guangdong Provincial People's Hospital
      • Contact: Dong Zhou
    • Guangzhou, Guangdong, China, 510280
      • Not yet recruiting
      • Zhujiang Hospital of Southern Medical University
      • Contact: Chuanzhi Duan
    • Guangzhou, Guangdong, China, 510515
      • Not yet recruiting
      • Nan Fang Hospital
      • Contact: Songtao Qi
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Not yet recruiting
      • The First Affiliated Hospital of Harbin Medical University
      • Contact: Huaizhang Shi
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • Henan Provincial People's Hospital
      • Contact: Tianxiao Li
  • Hubei
    • Wuhan, Hubei, China, 430071
      • Not yet recruiting
      • Zhongnan Hospital of Wuhan University
      • Contact: Jincao Chen
  • Jiangsu
    • Changzhou, Jiangsu, China
      • Not yet recruiting
      • The First People's Hospital of Changzhou
    • Nanjing, Jiangsu, China, 210008
      • Not yet recruiting
      • Nanjng Drum Tower Hospital
      • Contact: Chunhua Hang
    • Nanjing, Jiangsu, China
      • Not yet recruiting
      • General Hospital of Eastern Theater Command
      • Contact: HanDong Wang
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Not yet recruiting
      • The Second Affiliated Hospital of Nanchang University
      • Contact: Xingen Zhu
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai Changhai Hospital
      • Contact: Jianmin Liu, Doctor
    • Shanghai, Shanghai, China
      • Not yet recruiting
      • Huashan Hospital ,Fudan University
      • Contact: Yuxiang Gu, Doctor
  • Zhejiang
    • Hangzhou, Zhejiang, China, 322000
      • Not yet recruiting
      • The Second Affiliated Hospital of Zhejiang University School of Medicine
      • Contact: Jianmin Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective embolization rate of malformed masses	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.	Immediately after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRS score	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 .	1,6,12months after surgery
Technical success rate	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	Immediately after surgery
Catheter performance evaluation	The ability of the catheter to reach the lesion .; The catheter has broken at the tip and perforated.; Intravascular complications associated with catheters occurred.; Degree of difficulty in tube withdrawal; Catheter jam	Immediately after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of major adverse events related to device or surgical procedures within 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.	1 month after surgery

Collaborators and Investigators

• Sponsor: Suzhou Hengruihongyuan Medical Technology Co. LTD

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2021
• Primary Completion (Anticipated): October 17, 2023
• Study Completion (Anticipated): October 17, 2024

Study Registration Dates

• First Submitted: September 24, 2021
• First Submitted That Met QC Criteria: September 24, 2021
• First Posted (Actual): September 27, 2021

Study Record Updates

• Last Update Posted (Actual): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Non-adhesive Liquid Embolic System
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Cardiovascular Abnormalities; Neoplasms, Vascular Tissue; Nervous System Malformations; Vascular Malformations; Intracranial Arterial Diseases; Central Nervous System Vascular Malformations; Congenital Abnormalities; Hemangioma; Arteriovenous Malformations; Intracranial Arteriovenous Malformations
• Other Study ID Numbers: Nal01

Drug and device information, study documents

• 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