intracranial aneurysms
Conditions
Interventions
Experimental group:Using the intratumoral blood flow guiding device produced by Shanghai Xinwei Medical Technology Co., Ltd.
Sponsors
UNION HOSPITAL TONGJI MEDICAL COLLEGE HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. There are no restrictions on men and women aged = 18 years and = 80 years old; 2. The target aneurysm was confirmed by imaging diagnosis before operation as untreated single intracranial bifurcation aneurysm (2.0 > aneurysm body width/aneurysm neck > 1.25); 3. The aneurysm is located at the end of internal carotid artery or the top of basilar artery at the bifurcation of middle cerebral artery. 4. Patients or their guardians voluntarily participate and sign written informed consent to accept the examination and follow-up stipulated in the program.
Exclusion criteria
Exclusion criteria: 1. The target aneurysm is an aneurysm that has undergone craniotomy, clipping, vascular embolization and other endovascular interventional therapy or needs fractional operation; 2. The target aneurysm is fusiform aneurysm, dissecting aneurysm, pseudoaneurysm, vesicular aneurysm, infectious aneurysm, arteriovenous malformation related aneurysm, moyamoya disease related aneurysm; 3. Severe stenosis or tortuosity of intracranial artery or anatomical abnormality. Researchers evaluate that it is difficult for instruments to reach the lesion site; 4. Those who have known contraindications for antiplatelet or/and anticoagulant therapy; 5. Patients with severe liver and kidney function (ALT > 3 times of normal upper limit; Creatinine > 450umol/L); 6. The patient has previously identified the allergic history of metal materials such as nickel, titanium, platinum and iridium; 7. The patient has a history of severe allergy to contrast media (excluding rash); 8. The researcher assessed that the life expectancy was less than 12 months and could not complete the research cycle; 9. Pregnant or lactating women; 10. Patients who are participating in clinical studies of other drugs or devices and have not completed the follow-up of the main endpoint; 11. According to the researchers, it is not suitable to treat intracranial aneurysms with intratumoral blood flow guiding devices
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of aneurysm treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete occlusion rate;Apparatus success rate;Success rate of operation;Successful occlusion rate of aneurysm;Stenosis rate of vessel in tumor-bearing segment;Mortality;Stroke rate;Good rate of improved Rankin score;Incidence of device-related adverse events and serious adverse events; | — |
Countries
China
Contacts
Public ContactFeng Jun
UNION HOSPITAL TONGJI MEDICAL COLLEGE HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY
Outcome results
None listed