Intra-Arterial Bevacizumab as an Adjunct to Middle Meningeal Artery Embolization for Chronic Subd… (NCT07729098) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Intra-Arterial Bevacizumab as an Adjunct to Middle Meningeal Artery Embolization for Chronic Subdural Hematoma
18 participantsStarted 2027-01-01
Plain-language summary
This is a Phase 1, open-label, single-center, dose-escalation study evaluating the safety and tolerability of intra-arterial bevacizumab (IA-BEV) given as an adjunct to middle meningeal artery embolization (MMAE) in adults with non-surgical chronic subdural hematoma (cSDH). Up to 18 participants who are already scheduled to undergo MMAE as standard of care will receive a single dose of bevacizumab, delivered directly into the middle meningeal artery immediately before embolization, during the same procedure. Three dose levels (2.0, 3.5, and 5.0 mg/kg) will be tested using a standard 3+3 dose-escalation design to identify the maximum tolerated dose. The study will also collect imaging and blood biomarker data to help understand which patients may benefit most from this combined treatment approach.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18-85 years
* Scheduled to undergo MMAE as standard of care for cSDH, no concurrent surgical evacuation planned (prior surgery for the target cSDH allowed if ≥14 days elapsed)
* Radiographically confirmed cSDH meeting specified unilateral/bilateral density criteria
* cSDH volume 20-100 cc
* Midline shift \<8 mm
* Markwalder Grade 1 or 2
* Subject or LAR able to provide written informed consent
Exclusion Criteria:
* Requires immediate/urgent surgical evacuation
* Prior large craniotomy, membranectomy, or MMAE for the current target cSDH
* Life expectancy \<1 year
* Uncontrolled bleeding disorder (INR \>1.7, aPTT \>35s, platelets \<100,000/μL)
* Concurrent intracranial hemorrhage outside the target subdural space
* Persistent neurological deficit from another acute/chronic neurological condition
* Pregnancy or lactation
* Known/suspected intracranial neoplasm or mass lesion
* Active alcohol/substance use disorder within 12 months
* Baseline mRS ≥3
* Uncontrolled severe hypertension (SBP \>220 or DBP \>120, or IV antihypertensive need within 24h pre-procedure)
* Thromboembolic event within 6 months (DVT, PE, TIA, stroke)
* Contraindication to VTE prophylaxis
* eGFR \<60 mL/min/1.73m² or acute kidney injury at screening
* Known hypersensitivity to bevacizumab or its components
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.