Intracranial Aneurysm Clinical Trial
Official title:
Bare Platinum Coils Versus Second-generation Hydrocoils for the Endovascular Treatment of Ruptured Intracranial Aneurysms: a Randomized Controlled Study
Comparison of clinical and radiological outcomes between bare platinum coil group and second-generation hydrogel coils for treatment of ruptured intracranial aneurysms.
Status | Recruiting |
Enrollment | 118 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Chungnam National University Sejong Hospital | Sejong | Chungnam |
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si | |
Korea, Republic of | Pusan National University Yangsan Hospital | Yangsan | Gyeongsangnam-do |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital | Chungnam National University Sejong Hospital, Pusan National University Yangsan Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | recurrence rate after treatment | recurrence rate at 12 months after coil embolization | during 12 months after coil embolization | |
Secondary | Rates of thromboembolic and hemorrhagic complications | Rates of thromboembolic and hemorrhagic complications | during 12 months after coil embolization | |
Secondary | Rate of periprocedural complications | Rate of periprocedural complications | within 30 days after coil embolization | |
Secondary | Assessment of clinical outcomes using modified Rankin Scale scores | Modified Rankin Scale scores (0-6, higher scores mean a worse outcome) | during 12 months after coil embolization |
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