Cerebrovascular malformation
Conditions
Interventions
Experimental group:The hydrophobic liquid embolizer kit produced by Shanghai Isimiol Medical Instruments Co., Ltd. was used for treatment
Control group:The Onyx Liquid Embolic System, manufactured by Micro Therapeutics Inc. DBAev3 Neurovascular, was used for treatment
Sponsors
Xuanwu Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.18 years old = age =80 years old, gender is not limited; 2. Patients diagnosed with cerebrovascular malformations by imaging examination; 3. Cerebrovascular malformations meet any of the following characteristics: a has ruptured; b has not ruptured, but has bleeding risk factors or related symptoms or causes high anxiety and affects work and life; 4. The subject or his/her guardian is willing to comply with the protocol requirements and data collection procedures, understand and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with intracranial hemorrhage within the last 1 month; 2. Patients with severe stenosis or occlusion of the interventional pathway that affects interventional therapy; 3. Patients with =2 cerebrovascular malformations requiring simultaneous treatment, or other intracranial vascular malformations such as cerebral cavernous vascular malformations that cannot be treated by embolization surgery; 4. This operation requires other methods to treat patients with blood supply aneurysms related to the target malformed vascular region; 5. Patients who have previously received embolization interventional therapy for target vessels or have had embolization interventional therapy for non-target vessels within 30 days before surgery; 6. Patients with brain tumors scheduled for surgery within the last 3 months; 7. Patients with mRS=3 due to neurological dysfunction; 8. Patients who cannot tolerate anesthesia, or are allergic to heparin and iodine; 9. Patients with severe liver injury (AST or ALT exceeding 3 times the upper limit of normal) or severe renal function injury (serum creatinine >1.5 times the upper limit of normal) that cannot be corrected; 10. Platelets (PLT)1.5, or patients with bleeding disorders; (11) Pregnant or lactating women, or those who plan to become pregnant within one year or whose spouse plans to become pregnant; 12. Those who are participating in clinical trials of other interventional medical devices or drugs; 13. Other conditions determined by the investigator to be unsuitable for participation in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Targeted embolization success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Instrument success rate;Instrument performance evaluation;Changes of mRS Scores from baseline at 1, 3, 6 and 12 months after embolization;Proportion of patients with mRS Scores >2 at 1, 3, 6 and 12 months after embolization; | — |
Countries
China
Contacts
Public ContactZhang Hongqi
Xuanwu Hospital, Capital Medical University
Outcome results
None listed