Intracranial aneurysm
Conditions
Interventions
Experimental group:Blood flow guidance devices were implanted
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, male or non-pregnant female; 2. Untreated and unruptured intracranial wide-necked aneurysm confirmed by preoperative imaging diagnosis (wide-necked aneurysm is defined as aneurysm neck >=4mm or tumor body/tumor neck ratio <2); 3. The target aneurysm is planned to be embolized only with a blood flow diversion device, and embolization is not required to be completed in stages; 4. The width of the tumor neck should be <=30mm; 5. The diameter of the parent artery is 1.5mm6.5mm by imaging measurement; 6. The subjects or their legal guardians can understand the purpose of the research, show sufficient compliance with the research protocol, and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. The target aneurysm is blood blister-like aneurysm, pseudoaneurysm or arteriovenous malformation, aneurysm related to moyamoya disease; 2. DSA indicates that the vascular path is tortuous or has severe arteriosclerosis, and it is difficult for the device to reach the target blood vessel; 3. Patients who cannot receive antiplatelet aggregation and/or anticoagulation therapy; 4. Patients with known allergies to nickel-titanium alloys and platinum-tungsten alloys; 5. Those who are known to be severely allergic to contrast media (rashes are not counted); 6. Patients with known dementia or mental illness; 7. Patients with severe heart, liver, kidney, respiratory system diseases and coagulation disorders before surgery; 8. Life expectancy is less than 1 year; 9. Participating in any other drug or medical device clinical trial, or may participate in any other drug or medical device clinical trial after enrolling in this clinical trial; 10. The investigator judges that there are other circumstances that are not suitable for participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of radiographically confirmed complete aneurysm occlusion (Raymond score: grade I) at 12 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate postoperative success rate (implant placement success rate);The parent artery was unobstructed (stenosis rate <=50%) at 12 months after surgery and no reintervention was performed;The self-care rate 12 months after surgery (mRS 0-2); | — |
Countries
China
Contacts
Public ContactLiu Aihua
Outcome results
None listed