Bare Platinum Coils Versus Second-generation Hydrocoils

Seoul National University Hospital68 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aneurysm, Ruptured Intracranial Aneurysm

Interventions

Coil embolizationDEVICE

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

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (3)

Chungnam National University Sejong Hospital

Sejong, Chungcheongnam-do, South Korea

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Outcomes

Primary Outcomes

any recurrence rate after treatment

any recurrence rate at 12 months after coil embolization

Time frame: during 12 months after coil embolization

Secondary Outcomes

rate of retreatment during 12 months follow-up period

Time frame: rate of retreatment during 12 months follow-up period

packing density (%) after coil embolization

Time frame: packing density (%) after coil embolization

Procedural complication

Time frame: during coil embolization

delayed cerebral ischemia during 12-month follow-up period

Time frame: delayed cerebral ischemia during 12-month follow-up period

good clinical outcome (mRS score ≤ 2) at 12-month follow-up period

Time frame: good clinical outcome (mRS score ≤ 2) at 12-month follow-up period

rate of ventriculoperitoneal shunt during 12-month follow-up period

Time frame: rate of ventriculoperitoneal shunt during 12-month follow-up period

coil's ease of manipulation

Data from ClinicalTrials.gov

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