Bare Platinum Coils Versus Second-generation Hydrocoils

Not Applicable

Active, not recruiting

• Conditions: Aneurysm, Ruptured; Intracranial Aneurysm
• Interventions: Device: Coil embolization

• 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
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2025-10-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 118

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

Arm && Interventions

Group	Intervention	Description
Second-generation hydrogel coil group	Coil embolization	Treatment using second-generation hydrogel coils (had to constitute \> 50% of the total coil length) for ruptured cerebral aneurysms
Bare platinum coil group	Coil embolization	Treatment using bare metal coil only for ruptured cerebral aneurysms

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Rates of thromboembolic and hemorrhagic complications	during 12 months after coil embolization	Rates of thromboembolic and hemorrhagic complications
Rate of periprocedural complications	within 30 days after coil embolization	Rate of periprocedural complications
Assessment of clinical outcomes using modified Rankin Scale scores	during 12 months after coil embolization	Modified Rankin Scale scores (0-6, higher scores mean a worse outcome)

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