Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2025-12-24 @ 6:34 PM
NCT ID:
NCT07075757
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 and \< 65 years at the time of inclusion
2. bAVM (i.e.: located in the brain, brain stem or cerebellum)
3. Spetzler-Martin grade IV - V on a brain MRI performed less than 2 months before inclusion
4. History of rupture and/or with intractable symptoms related to the bAVM (i.e.: intractable seizure, steal phenomenon, compressive symptoms)
5. bAVM deemed unsuitable for exclusion invasive treatment
6. Adequate bone marrow function at inclusion :
* Hemoglobin (Hb) levels more than 13.5 g/dL in males and Hb levels more than 12.5 g/dL in females.
* Platelet count ≥ 150 G/L
* Leukocytes count ≥ 3000/μL
* Neutrophils count ≥ 1500/μL
7. Normal liver function (alanine transaminase \[ALT\] \< 56 UI/L and aspartate aminotransferase \[AST\] \< 40 UI/L) at inclusion
8. Normal renal function (creatinine clearance ≥ 30 ml/min calculated with the Cockcroft-Gault formula) at inclusion
9. Complete COVID-19 vaccinal scheme, according to the French recommendations
10. Affiliation to French Healthcare system (AME excluded)
11. Signed informed consent
Exclusion Criteria:
1. Diffuse bAVM (like proliferative angiopathy) that cannot be assessed in terms of volume by cross-sectional imaging on MRI
2. Inability/contraindication to undergo MRI (Pacemaker, iron metallic items, cochlear implants, claustrophobia)
3. Coagulation disorders (prothrombin time \< 50% or Platelet count \< 150 G/L)
4. Any congenital predisposition to coagulation disorder
5. Any disease requiring full anticoagulation
6. History of cancer, except baso-cellular carcinoma
7. Congestive cardiac failure
8. Pre-existing coronary disease
9. Unstable medical or psychiatric illness
10. Any history of clinically significant thrombotic episode within the last 6 months
11. Any history of atrial fibrillation
12. Proteinuria (albumin excretion rate \> 30 mg/day)
13. Blood hypertension grade ≥ II (CTACE v5.0, 2017)
14. Past history of a gastro-intestinal fistula
15. Past history of a vaginal fistula
16. Past history of open surgery within the last 28 days
17. Infectious syndrome within the last month
18. Any other contra-indication to bevacizumab administration
19. Any contra-indication to general anesthesia
20. Pregnancy or lactating woman
21. Woman without efficacy contraception (combined hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, sexual abstinence) all along study participation, and until 6 months after the bevacizumab administration, for woman of childbearing potential
22. Seropositivity for HIV, HCV or HBV
23. Severe and proven allergy to iodinated contrast material or Gadolinium
24. Participation in another interventional clinical trial evaluating a health product or any randomized clinical trial
25. Patients under legal protection (tutorship or curatorship) and patient deprived of freedom
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07075757
Study Brief:
Protocol Section:
NCT07075757