Bare Platinum Coils Versus Second-generation Hydrocoils

Not Applicable

Terminated

• Conditions: Aneurysm, Ruptured; Intracranial Aneurysm

• Registration Number: NCT04988503
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2021-07-23
• Study First Submitted QC: 2021-07-23
• Study First Posted: 2021-08-03
• Study Start: 2021-08-30
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-07-21
• Last Update Posted: 2025-07-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
any recurrence rate after treatment	during 12 months after coil embolization	any recurrence rate at 12 months after coil embolization

Secondary Outcome Measures

Name	Time	Method
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
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
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
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

Trial Locations

Locations (3)

Chungnam National University Sejong Hospital; 🇰🇷 Sejong, Chungnam, Korea, Republic of

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Gyeongsangnam-do, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Korea, Republic of