intracranial aneurysm
Conditions
Interventions
Experimental group:Electrocautery guidewires and direct current electrocautery devices
Sponsors
Xuanwu Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Aged between 18 and 80 years, inclusive, regardless of gender. 2. Subjects who meet any of the following clinical scenarios: (1) Patients with intracranial small or tiny aneurysms where the microcatheter is unable or difficult to perform superselective catheterization, or where coiling is not feasible. (2) Patients with intracranial aneurysms scheduled to undergo standalone coil embolization therapy. (3) Patients with intracranial aneurysms scheduled to undergo standalone flow-diverting stent therapy. 3. Subjects or their legal guardians are able to understand the study objectives, willing to cooperate with the surgical procedure and follow-up assessments, and voluntarily participate in the trial by providing written informed consent.
Exclusion criteria
Exclusion criteria: 1. Having undergone craniotomy clipping or other cerebrovascular intervention within 30 days prior to enrollment. 2. Having received prior surgical treatment for the target aneurysm. 3. Presence of other intracranial diseases requiring surgical intervention within 12 months post-procedure, besides the target aneurysm. 4. Severe dissection, extreme tortuosity, severe cerebrovascular spasm, or >50% stenosis due to atherosclerosis in the vascular access route, making it anticipated that the investigational device would be difficult to reach the target lesion. 5. Patients who, according to the Chinese Expert Consensus on Flow Diverter Treatment for Intracranial Aneurysms [11], require combined use of a flow-diverting stent and coils. 6. Modified Rankin Scale (mRS) score = 4. 7. The target aneurysm is a pseudoaneurysm, or is associated with conditions such as arteriovenous malformation or moyamoya disease. 8. Patients unable to receive antiplatelet and/or anticoagulant therapy. 9. Known allergy to the anticipated implantable devices or documented allergy to contrast agents. 10. Known diagnosis of dementia or mental illness preventing cooperation with the trial. 11. Pre-existing severe cardiac, hepatic, renal, respiratory diseases, or known coagulation disorders. 12. Life expectancy less than 1 year. 13. Currently participating in any other drug or medical device clinical trial and have not yet reached the study endpoint. 14. Pregnant or lactating women, or women with a positive pregnancy test. 15. Any other condition that, in the opinion of the investigator, renders the subject unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete occlusion rate of the target aneurysm at 3 months post-procedure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success rate;Immediate post-procedure complete occlusion rate of the target aneurysm;Complete occlusion rates of the target aneurysm at 6 and 12 months post-procedure;Incidence of no significant stenosis in the parent artery (<50%);mRS score; | — |
Countries
China
Contacts
Public ContactZhang Hongqi
Xuanwu Hospital, Capital Medical University
Outcome results
None listed