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

Intracranial Arteriovenous Malformations Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05058482
• Other study ID #: Nal01
• Status: Recruiting
• Phase: N/A
• Start date: December 2, 2021
• Est. completion date: October 17, 2024

Study information

• Verified date: September 2021
• Source: Suzhou Hengruihongyuan Medical Technology Co. LTD
• Contact: Jianmin Liu, Doctor
• Phone: 13901780638
• Email: liu118[@]vip.163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: October 17, 2024
• Est. primary completion date: October 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arteriovenous Malformations
• Congenital Abnormalities
• Hemangioma
• Intracranial Arteriovenous Malformations

Intervention

Device:
• embolism
Cerebral arteriovenous malformation embolism

Locations

Country	Name	City	State
China	The First People's Hospital of Changzhou	Changzhou	Jiangsu
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	Nan Fang Hospital	Guangzhou	Guangdong
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	General Hospital of Eastern Theater Command	Nanjing	Jiangsu
China	Nanjng Drum Tower Hospital	Nanjing	Jiangsu
China	Huashan Hospital ,Fudan University	Shanghai	Shanghai
China	Shanghai Changhai Hospital	Shanghai	Shanghai
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Hengruihongyuan Medical Technology Co. LTD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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