Bare Platinum Coils Versus Second-generation Hydrocoils

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-30

Study Completion Date

2025-02-28

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.

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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.

Conditions

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Aneurysm, Ruptured Intracranial Aneurysm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

bare platinum coils group versus second-generation hydrogel coil group

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Second-generation hydrogel coil group

Treatment using second-generation hydrogel coils (had to constitute \> 50% of the total coil length) for ruptured cerebral aneurysms

Group Type EXPERIMENTAL

Coil embolization

Intervention Type DEVICE

coil embolization for ruptured intracranial aneurysm with bare platinum coils or second-generation hydrogel coils

Bare platinum coil group

Treatment using bare metal coil only for ruptured cerebral aneurysms

Group Type ACTIVE_COMPARATOR

Coil embolization

Intervention Type DEVICE

coil embolization for ruptured intracranial aneurysm with bare platinum coils or second-generation hydrogel coils

Interventions

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Coil embolization

coil embolization for ruptured intracranial aneurysm with bare platinum coils or second-generation hydrogel coils

Intervention Type DEVICE

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