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New treatment option for Brain Arteriovenous Malformation
Official title The Liquid Embolic Agent for the Treatment of Brain Arteriovenous Malformation
ClinicalTrials.gov ID: NCT07314047
What this study is testing
- What it's testing
- This study is designed as a prospective, multi-center, open-label, non-inferiority, randomized controlled clinical trial. The control device is Onyx Liquid Embolic System marketed by Micro Therapeutics Inc.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age ≥ 18 and ≤ 80 years at the time of signing the informed consent
- people with brain arteriovenous malformation diagnosed by CT/MRI/DSA
- The target brain arteriovenous malformation is classified by Spetzler-Martin in the range of Ⅰ \~ Ⅳ
- people themselves and/or their guardian are able to understand the purpose of the study, consent to participate, and sign the informed consent form
- Brain arteriovenous malformations deemed suitable for liquid embolic agent intervention as assessed by the investigator
You likely can't join if
- Multiple brain arteriovenous malformations
- Brain arteriovenous malformation complicated with blood flow-related aneurysm that may require staged and delayed treatment using other methods...
- Brain arteriovenous malformation with a history of stereotactic radiosurgery within 3 years
- Brain arteriovenous malformation with bleeding within 1 week
- Brain arteriovenous malformation with an expected number of embolizations ≥ 4
- Brain arteriovenous malformation scheduled for surgical resection after embolization
See the full eligibility criteria
- Age ≥ 18 and ≤ 80 years at the time of signing the informed consent
- people with brain arteriovenous malformation diagnosed by CT/MRI/DSA
- The target brain arteriovenous malformation is classified by Spetzler-Martin in the range of Ⅰ \~ Ⅳ
- people themselves and/or their guardian are able to understand the purpose of the study, consent to participate, and sign the informed consent form
- Brain arteriovenous malformations deemed suitable for liquid embolic agent intervention as assessed by the investigator
- Multiple brain arteriovenous malformations
- Brain arteriovenous malformation complicated with blood flow-related aneurysm that may require staged and delayed treatment using other methods within the one-year follow-up period
- Brain arteriovenous malformation with a history of stereotactic radiosurgery within 3 years
- Brain arteriovenous malformation with bleeding within 1 week
- Brain arteriovenous malformation with an expected number of embolizations ≥ 4
- Brain arteriovenous malformation scheduled for surgical resection after embolization
- mRS score ≥ 3
- people unsuitable for anesthesia or endovascular surgical treatment, due to major diseases of cardio, lung, liver, spleen or kidney, malignant brain tumors, severe active infection, disseminated intravascular...
- people who undergo major surgical procedures (such as tumor resection, vital organ surgery, etc.) within 30 days prior to signing the informed consent form, or those scheduled for such procedures within 60 days after...
- Contraindications for liquid embolic agent treatment, including but not limited to: contraindications for DSA, severe allergy or intolerance to contrast agents, severe allergy or intolerance to antiplatelet or...
- Pregnant or lactating women
- people participating in other drug or device studies that have not reached their endpoints or who have just withdrawn from the group for less than one month
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.