Intracranial Arteriovenous MalformationsNCT05058482
Non-adhesive Liquid Embolic System in the Embolization of Cerebral Arteriovenous Malformations
A study testing embolism in people with Intracranial Arteriovenous Malformations, run by Suzhou Hengruihongyuan Medical Technology Co. LTD at 13 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intracranial Arteriovenous Malformations
- What is being tested?
- embolism
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 13 sitesChina
- Study dates
- 2 Dec 2021to 17 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Complicated with proliferative cerebrovascular disease.
- Pregnant or lactating women.
- Participants who have participated in other clinical trials within the last 3 months and failed to reach the end point.
- The number of embolism is expected to be greater than or equal to 4 times during the study period (within 1 year).
- Subjects deemed unsuitable for this study by the investigator.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites, 13 recruiting
- Not yet recruiting
The First People's Hospital of Changzhou
Changzhou, Jiangsu
Ya Peng
- Not yet recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280
Chuanzhi Duan
- Not yet recruiting
Nan Fang Hospital
Guangzhou, Guangdong, 510515
Songtao Qi
- Not yet recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Dong Zhou
- Not yet recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 322000
Jianmin Zhang
- Not yet recruiting
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Huaizhang Shi
- Not yet recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Xingen Zhu
- Not yet recruiting
Nanjng Drum Tower Hospital
Nanjing, Jiangsu, 210008
Chunhua Hang
- Not yet recruiting
General Hospital of Eastern Theater Command
Nanjing, Jiangsu
HanDong Wang
- Not yet recruiting
Huashan Hospital ,Fudan University
Shanghai, Shanghai Municipality
Yuxiang Gu, Doctor
- Recruiting
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality
Jianmin Liu, Doctor
- Not yet recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Jincao Chen
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan
Tianxiao Li
About this study
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
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.
Read the 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.
- Conditions
- Intracranial Arteriovenous Malformations
- Being tested
- embolism
- Keywords
- Non-adhesive Liquid Embolic System
- Medical subject headings
- Intracranial Arteriovenous Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
embolismDevice
Cerebral arteriovenous malformation embolism
| Study group | Role | What they receive |
|---|---|---|
| Non-adhesive Liquid Embolic System(NALES) | Experimental | Not described Receives: Device: embolism |
| Onyx Liquid Embolic System& Marathon Flow Directed Micro Catheter | Active comparator | Not described Receives: Device: embolism |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after surgery
Secondary outcomes (3)
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 .
Measured: 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
Measured: 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
Measured: Immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start2 Dec 2021
- Primary completion17 Oct 2023 (estimated)
- Study completion17 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Arteriovenous MalformationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Hengruihongyuan Medical Technology Co. LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058482
- Sponsor's protocol ID
- Nal01
- Status last verified
- Sep 2021
- First submitted
- 24 Sep 2021
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05058482
- Acronym / sponsor ID
- Nal01
- Conditions
- Intracranial Arteriovenous Malformations
- Keywords
- Non-adhesive Liquid Embolic System
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Suzhou Hengruihongyuan Medical Technology Co. LTDIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 17 Oct 2023 (estimated)
- Study completion
- 17 Oct 2024 (estimated)
- First posted
- 27 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-adhesive Liquid Embolic System(NALES) | Experimental | Device: embolism |
| Onyx Liquid Embolic System& Marathon Flow Directed Micro Catheter | Active comparator | Device: embolism |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| embolismCerebral arteriovenous malformation embolism | Device | Non-adhesive Liquid Embolic System(NALES), Onyx Liquid Embolic System& Marathon Flow Directed Micro Catheter |
Primary outcome
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.
3 secondary outcomes
MRS score
Time frame: 1,6,12months after surgery
Technical success rate
Time frame: Immediately after surgery
Catheter performance evaluation
Time frame: Immediately after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing embolism in people with Intracranial Arteriovenous Malformations, run by Suzhou Hengruihongyuan Medical Technology Co. LTD at 13 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianmin Liu, Doctor (13901780638, liu118@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective embolization rate of malformed masses (time frame: Immediately after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.