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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intracranial Arteriovenous Malformations
- Sponsor
- Suzhou Hengruihongyuan Medical Technology Co. LTD
- Enrollment
- 116
- Locations
- 13
- Primary Endpoint
- Effective embolization rate of malformed masses
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18-70 years old, no gender limit.
- •The patient was diagnosed as cerebral arteriovenous malformation .
- •The patient had no history of bAVM treatment, including intervention, surgery or radiotherapy .
- •Spetzler Martin, grade I-IV .
- •The patient voluntarily signed the informed consent.
Exclusion Criteria
- •History of heparin allergy.
- •The patient is allergic to contrast media.
- •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).
- •Patient has irreversible coagulopathy (INR \> 1.5).
- •Intracranial hemorrhage 1 week before treatment.
- •MRS ≥4 due to neurological dysfunction.
- •Patients with planned malformation resection after embolization.
- •Blood flow related aneurysms of supplying artery that need to be treated by other methods.
- •Complicated with severe cerebral artery stenosis.
- •Brain tumors that require recent surgery.
Outcomes
Primary Outcomes
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 Outcomes
- Catheter performance evaluation(Immediately after surgery)
- Technical success rate(Immediately after surgery)
- MRS score(1,6,12months after surgery)