Wide-neck bifurcation cerebral aneurysms suitable for endovascular treatment Cerebral Aneurysm
Conditions
Interventions
Sponsors
Sakai Chiaki
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age at the time of informed consent: 18 years or older and 80 years or younger 2. Unruptured cerebral aneurysms; ruptured cerebral aneurysms in the chronic phase; or ruptured cerebral aneurysms in the acute phase classified as WFNS Grade I-III 3. For unruptured and ruptured cerebral aneurysms in the chronic phase, the Modified Rankin Scale (mRS) score must be 2 or lower prior to treatment; for ruptured cerebral aneurysms in the acute phase, the mRS score must be 2 or lower prior to rupture 4. Written informed consent has been obtained 5. Saccular aneurysms at a wide-neck bifurcation (dome-to-neck ratio = 4 mm) with a maximum aneurysm diameter of 5 mm or more and a short-axis neck diameter of 6 mm or less, for which treatment with detachable coils is appropriate
Exclusion criteria
Exclusion criteria: 1. A stent is in place in the neck of the target aneurysm 2. Administration of heparin or antiplatelet agents is not possible for medical reasons 3. History of allergy to metals (e.g., platinum, tungsten alloys, etc.) 4. History of severe contrast agent allergy 5. Has other intracranial lesions scheduled for treatment within the next 6 months 6. Unable to undergo 6 months of follow-up 7. The participant is currently participating in another clinical trial 8. The participant is pregnant, may be pregnant, or is not using contraception (women only) 9. Any other circumstances deemed inappropriate by the principal investigator (or co-investigator) for participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of cases that met all of the following criteria 1 through 3 on angiography 6 months after treatment 1. The coil mass remains within the cerebral aneurysm 2. Curative occlusion has been achieved 3. No additional treatment has been performed on the target aneurysm | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Technical success rate of treatment (the investigational device was properly deployed, and a coil mass was placed within the cerebral aneurysm) 2. Procedural success rate of treatment (technically successful with no serious adverse events attributable to the treatment or procedure and no device malfunctions) 3. Rate of curative occlusion of the target aneurysm 6 months after treatment 4. Proportion of patients who underwent additional treatment by 6 months post-treatment 5. Proportion of severe strokes or neurological deaths attributable to the treatment or device within 6 months post-treatment 6. Total number of deaths within 30 days of treatment and over the 6-month period 7. Number of deaths due to cerebrovascular causes within 30 days of treatment and over the 6-month period 8. Number of total stroke cases within 30 days of treatment and over the 6-month period 9. Number of stroke cases in the treated vascular territory within 30 days of treatment and over the 6-month period 10. Number of severe stroke cases in the treated vascular territory within 30 days of treatment and over the 6-month period 11. Incidence rate of serious adverse events within 30 days of treatment and over the 6-month period 12. Device malfunctions | — |
Contacts
Public ContactKeiji Kanda
Kyoto University Hospital
Outcome results
None listed