Patients with wide-neck cerebral bifurcation aneurysms indicated for endovascular treatment Intracranial Aneurysm
Conditions
Interventions
Sponsors
Sakai Chiaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age is >=18 and = 4 mm) suitable for treatment with detachable coil 4. With mRS score <= 2 before treatment for unruptured aneurysms and prior to rupture for ruptured aneurysms 5. Written informed consent has been obtained
Exclusion criteria
Exclusion criteria: 1. The index aneurysm has been treated previously by surgical treatment (including clipping) or endovascular treatment 2. Inability to administer heparin or antiplatelet agents for medical reasons 3. History of severe allergy to nickel-titanium alloy, platinum or stainless steel 4. History of severe allergy to contrast media 5. Has other intracranial lesions scheduled for treatment within 6 months 6. Difficult to follow-up for 6 months 7. Currently participating in another clinical trial that may affect the evaluation of this clinical trial 8. Pregnant or possibly pregnant or unwilling to use contraception (women only) 9. Other conditions that the investigator or sub-investigator deems inappropriate to conduct this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical success rate Clinical success is defined as meeting all of the following three conditions: 1. Angiography 6 months after treatment shows that the coil mass is maintained within the cerebral aneurysm 2. Angiography 6 months after treatment shows that a curative occlusion has been achieved 3. No additional treatment*3 was performed on the treated aneurysm within 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Technical success of treatment (proper implantation of the investigational device and placement of the coil mass into the cerebral aneurysm) 2. Procedural success of treatment (technically successful with no serious adverse events and/or device malfunctions attributable to the treatment or procedure) 3. Curative occlusion* of the index aneurysm at 6 months post-treatment (* Raymond Roy Classification I and II) 4. Additional treatment on the index aneurysm within 6 months post-treatment (limited to surgical treatment including endovascular treatment, excluding medication) 5. Severe stroke** or neurological death attributable to treatment or device within 6 months of index treatment (** NIHSS 4 points or more deterioration that lasts for 24 hours or more) 6. All-cause mortality within 30 days and 6 months post-treatment 7. Death attributable to cranial nerves within 30 days and 6 months post-treatment 8. All strokes within 30 days and 6 months post-treatment 9. Stroke in the treated vascular territory within 30 days and 6 months post-treatment 10.Severe stroke in the treated vascular territory within 30 days and 6 months post-treatment 11.Adverse events and their causal relationship with the investigational device within 30 days and 6 months post-treatment 12.Device malfunctions | — |
Contacts
Public ContactChiaki Sakai
Kyoto University Hospital
Outcome results
None listed