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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

Tracking Information
First Submitted Date  ICMJE September 24, 2021
First Posted Date  ICMJE September 27, 2021
Last Update Posted Date September 27, 2021
Estimated Study Start Date  ICMJE October 17, 2021
Estimated Primary Completion Date October 17, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2021)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2021)
  • 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 .
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 24, 2021)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Non-adhesive Liquid Embolic System in the Embolization of Cerebral Arteriovenous Malformations
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Intracranial Arteriovenous Malformations
Intervention  ICMJE Device: embolism
Cerebral arteriovenous malformation embolism
Study Arms  ICMJE
  • Experimental: Non-adhesive Liquid Embolic System(NALES)
    Intervention: Device: embolism
  • Active Comparator: Onyx Liquid Embolic System& Marathon Flow Directed Micro Catheter
    Intervention: Device: embolism
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 24, 2021)
116
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 17, 2024
Estimated Primary Completion Date October 17, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jianmin Liu, Doctor 13901780638 liu118@vip.163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05058482
Other Study ID Numbers  ICMJE Nal01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Suzhou Hengruihongyuan Medical Technology Co. LTD
Study Sponsor  ICMJE Suzhou Hengruihongyuan Medical Technology Co. LTD
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Suzhou Hengruihongyuan Medical Technology Co. LTD
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP