intracranial aneurysm
Conditions
Interventions
Study Group/ Control Group:mechanical detachable coil developed by Shanghai Wobby Medical Technology Co., Ltd vs marketing mechanical detachable coil
Sponsors
Beijing Tiantan Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years; 2. Has been diagnosed for intracranial aneurysms (small or large) by imaging diagnosis (CT, MRA or DSA) in the past 6-month; 3. Hunt-Hess Grade 0, I, II, III; 4. Patient who has been informed of the study and has signed an informed consent form where applicable according to local regulations.
Exclusion criteria
Exclusion criteria: 1. Determined by researcher that not eligible for intravascular interventional embolization treatment; 2. Liver and renal dysfunction (the ratios of ALT, AST are greater than the upper limit of normal 2 times); 3. Subject who has participated in other clinical trials in the past three months; 4. Subject who suffers from the disease which may cause treatment and evaluation difficulties (such as cancer, infection, severe metabolic diseases, mental illness, etc.), pregnancy, or presumed life expectancy of less than 1 year; 5. Woman of child-bearing potential who cannot provide a negative pregnancy test; 6. Known allergy or contraindication to aspirin, heparin, local or general anesthesia; 7. Known history of life threatening allergy to contrast dye; 8. Serum creatinine >= 2.5 mg/dL.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occlusion rate at 6 Months post procedure; | — |
Countries
China
Contacts
Public ContactLi Youxiang
Beijing Tiantan Hospital
Outcome results
None listed