Bare Platinum Coils Versus Second-generation Hydrocoils

Study Overview
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Brief Summary
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Comparison of clinical and radiological outcomes between bare platinum coil group and second-generation hydrogel coils for treatment of ruptured intracranial aneurysms.

Detailed Description
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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.

Official Title
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Bare Platinum Coils Versus Second-generation Hydrocoils for the Endovascular Treatment of Ruptured Intracranial Aneurysms: a Randomized Controlled Study

Conditions
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Aneurysm, Ruptured, Intracranial Aneurysm

Intervention / Treatment
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* Device: Coil embolization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: bare platinum coils group versus second-generation hydrogel coil group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Second-generation hydrogel coil group<br>Treatment using second-generation hydrogel coils (had to constitute > 50% of the total coil length) for ruptured cerebral aneurysms | Device: Coil embolization<br>* coil embolization for ruptured intracranial aneurysm with bare platinum coils or second-generation hydrogel coils<br>|
| Active Comparator: Bare platinum coil group<br>Treatment using bare metal coil only for ruptured cerebral aneurysms | Device: Coil embolization<br>* coil embolization for ruptured intracranial aneurysm with bare platinum coils or second-generation hydrogel coils<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence rate after treatment | recurrence rate at 12 months after coil embolization | during 12 months after coil embolization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of thromboembolic and hemorrhagic complications | Rates of thromboembolic and hemorrhagic complications | during 12 months after coil embolization | 
| Rate of periprocedural complications | Rate of periprocedural complications | within 30 days after coil embolization | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aneurysms, embolization, rupture