jawbone arteriovenous malformations
Conditions
Interventions
Experimental group:None
Sponsors
Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
3 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this clinical trial and sign the ICF, understand and follow the study procedures; 2. The subject is =3 years old and < 65 years old on the date of signing the informed consent, both male and female; 3. Patients with jaw arteriovenous malformation confirmed by digital subtraction angiography combined with clinical manifestations and imaging examination; 4. Body mass index (BMI, calculated by BMI= weight [kg]/ height 2[m2]) within the range of 18.5~28.0 kg/m2 (including boundary values); 5. with appropriate organ function: 1) Normal or abnormal blood routine indexes have no clinical significance; 2) Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =2.5× upper limit of normal (ULN), total bilirubin =1.5×ULN, baseline albumin =30 g/L; 3) Creatinine clearance =50 mL/min calculated according to an institutional standard practice assessment (based on the Cockcroft-Gault formula).
Exclusion criteria
Exclusion criteria: 1. Patients with a history of iodine contrast agent allergy; 2. Patients with edentulous jaws; 3. Active Infected persons: 1) Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; 2) Subjects who are HBV surface antigen (HBsAg) positive and/or HCV antibody positive during the screening period shall be tested for HBV DNA and/or HCV RNA. Participants with HBV DNA 1.0g was further determined; 8) Abnormal coagulation function (any of these abnormalities: Prothrombin time >3 s longer than ULN, activated partial thromboplastin time >10 s longer than ULN, international normalized ratio [INR]>2.0, fibrinogen < lower limit of normal [LLN]), or bleeding tendency, or receiving thrombolytic therapy, or anticoagulant therapy, Or diagnosed with localized intravascular coagulation (LIC); 5. The serum pregnancy test of female subjects with fertility was positive within 3 days before enrollment; 6. major surgery or other organ intervention, ablation treatment within 28 days before treatment; 7. If you have received live vaccine or attenuated live vaccine within 28 days prior to treatment, you are allowed to use seasonal influenza vaccine without live virus; 8. Participants who have participated in other clinical trials within 3 months before screening (based on the time of last use of the investigational drug); 9. Have a history of malignant tumor within 5 years prior to treatment, unless cured only by surgery and continued disease-free survival; 10. Any other medical, mental, or social condition that the researcher considers likely to impair the subject's rights, safety, welfare, or ability to sign the ICF, cooperate, and participate in the study, or that would interfere with the interpretation of the results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnosis of jawbone arteriovenous malformations;Diagnosis of periodontitis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of gingival inflammation in non-periodontitis patients; | — |
Countries
China
Contacts
Public ContactFan Xindong
Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed