Aneurysm, Ruptured, Intracranial Aneurysm
Conditions
Keywords
aneurysms, embolization, rupture
Brief summary
Comparison of clinical and radiological outcomes between bare platinum coil group and second-generation hydrogel coils for treatment of ruptured intracranial aneurysms.
Detailed description
The investigators aimed to analyze whether the use of second-generation hydrogel coils for the treatment of ruptured intracranial aneurysms improves clinical and angiographic outcomes compared with the use of bare platinum coils.
Interventions
DEVICECoil embolization
coil embolization for ruptured intracranial aneurysm with bare platinum coils or second-generation hydrogel coils
Sponsors
Pusan National University Yangsan Hospital
Chungnam National University Sejong Hospital
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
bare platinum coils group versus second-generation hydrogel coil group
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 19 year old or older * untreated ruptured intracranial aneurysms with an anatomy such that endovascular treatment with either bare platinum or second-generation hydrogel coils was considered feasible. * person who agreed to study
Exclusion criteria
* contrast allgery (+) * combined other intracranial lesions (tumor, moyamoya disease, cerebral vascular diseases) * ineligible for coil embolization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| any recurrence rate after treatment | during 12 months after coil embolization | any recurrence rate at 12 months after coil embolization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| packing density (%) after coil embolization | packing density (%) after coil embolization | packing density (%) after coil embolization |
| Procedural complication | during coil embolization | Procedural complication |
| delayed cerebral ischemia during 12-month follow-up period | delayed cerebral ischemia during 12-month follow-up period | delayed cerebral ischemia during 12-month follow-up period |
| rate of retreatment during 12 months follow-up period | rate of retreatment during 12 months follow-up period | rate of retreatment during 12 months follow-up period |
| rate of ventriculoperitoneal shunt during 12-month follow-up period | rate of ventriculoperitoneal shunt during 12-month follow-up period | rate of ventriculoperitoneal shunt during 12-month follow-up period |
| coil's ease of manipulation | during coil embolization | coil's ease of manipulation |
| good clinical outcome (mRS score ≤ 2) at 12-month follow-up period | good clinical outcome (mRS score ≤ 2) at 12-month follow-up period | good clinical outcome (mRS score ≤ 2) at 12-month follow-up period |
Countries
South Korea
Outcome results
None listed