Intra-Arterial Bevacizumab as an Adjunct to Middle Meningeal Artery Embolization for Chronic Subdural Hematoma | NCT07729098

NCT07729098

Overview

NCT ID: NCT07729098
Lead Sponsor: Dheeraj GandhiOTHER
Official Title: Safety And Efficacy of Intra-aRterial BEV (IA-BEV) as an Adjunctive Treatment During Middle Meningeal Artery Embolization (MMAE) in Non-Surgical Chronic Subdural Hematoma (cSDH) Patients
Brief 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.
Conditions

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Central Contacts: Kaitlyn Henry, MSContact
khenry@som.umaryland.edu410-328-0939