NCT07075757: BLITZ

In Situ Injection of Anti-angiogenics in Patients With Brain Arteriovenous Malformations Not Eligible for Exclusion Treatment

Not yet recruiting Phase 1 Last updated 20 July 2025

What this trial tests

Phase 1 trial testing Single in situ intra-arterial injection of bevacizumab in Brain Arteriovenous Malformations in 20 participants. Not yet recruiting.

Timeline

1 October 2025

Primary endpoint
1 November 2028

1 November 2028

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 1
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 October 2025
Primary completion	1 November 2028
Estimated completion	1 November 2028
Sites	5 locations across France

Drugs / interventions tested

• Single in situ intra-arterial injection of bevacizumab — full drug profile →

Conditions studied

• Brain Arteriovenous Malformations — all drugs for Brain Arteriovenous Malformations →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

Adults 18 to 65, any sex, with Brain Arteriovenous Malformations. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Brain arteriovenous malformations (bAVMs) are rare aggressive vascular malformations affecting mostly young and healthy adults. The most frequent revealing condition (in almost 50% of cases) is an intra-cerebral hemorrhage, which is a considerable source of disability and mortality. The only way to prevent a bleeding or a rebleeding is to perform an exclusion treatment (endovascular embolization, microsurgery, stereotactic radiosurgery, or a combination of these techniques). The major drawback of these treatments is the risk of severe complications, which can reach 20%, especially in patients presenting a bAVM with complex angio-architecture (i.e., grade IV to V in the Spetzler Martin grading scale). There is a growing evidence about the strong implication of angiogenesis (mainly mediated by the type A vascular endothelial growth factor \[VEGF-A\]) on the size and growth of the bAVM and even in the occurrence of bleeding events. Our hypothesis is that an in situ injection of bevacizumab, a monoclonal antibody inhibiting VEGF-A, in patients with bAVM deemed not suitable for exclusion treatment may be safe and help to reduce the nidus volume.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.