intracranial aneurysms
Conditions
Interventions
Experimental group:blood flow guide device manufactured by Shanghai HeartCare Medical Technology Co., Ltd.
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years; 2. Preoperative imaging diagnosis confirmed that the target aneurysm was untreated and unruptured intracranial wide-neck aneurysm (wide-neck aneurysm was defined as tumor neck >=4mm or tumor body/tumor neck ratio < 2), and the arteries included intracranial segment of internal carotid artery, intracranial segment of vertebral artery, anterior cerebral artery, middle cerebral artery, posterior cerebral artery, anterior communicating artery and posterior communicating artery, etc.; 3. The target vessel diameter is 1.5mm to 6.5mm; 4. Patients who voluntarily participate and sign written informed consent and can accept the examination and follow-up stipulated by the program.
Exclusion criteria
Exclusion criteria: 1. The target aneurysm is the aneurysm requiring multiple surgical treatment; 2. Target aneurysms are infectious aneurysms, vesicular aneurysms, pseudoaneurysms, arteriovenous malformation and moyamoya disease related aneurysms; 3. Severe intracranial artery stenosis or tortuosity, or anatomical abnormalities, and it is difficult for researchers to reach the lesion site with evaluation instruments; 4. Patients with severe heart, liver, kidney, respiratory system diseases and coagulopathy before surgery; 5. Patients with antiplatelet or/and anticoagulant therapy contraindications; 6. The patient has a clear history of allergies to platinum tungsten alloy and other metal materials; 7. The patient has a history of severe allergy to anesthetic drugs and contrast agents (rash is not included); 8. The life expectancy assessed by the investigator was less than 12 months, and the study period could not be completed; 9. Pregnant or lactating patients, or patients planning to have children in the next year; 10. The patient's blood type is rare; 11. For various reasons, the researchers judged that the blood flow guide device was not suitable for the treatment of intracranial aneurysm; 12. Patients who are participating in clinical studies of other drugs or devices and have not completed the primary study endpoint; 13. Other conditions deemed unsuitable for inclusion by the researcher.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Immediate surgical success rate;Intra-stent stenosis rate;Successful occlusion rate of aneurysm;Good rate of modified Rankin score (mRS<=2 points);Mortality rate;The incidence of device-related adverse events and serious adverse events;Complete occlusion rate;Incidence of diseased vessel-related stroke; | — |
Countries
China
Contacts
Public ContactYang Xinjian
Outcome results
None listed