ClinicalTrials.gg
TerminatedNCT04988503Updated Jul 25, 2025

Bare Platinum Coils Versus Second-generation Hydrocoils

An interventional study of Coil embolization in Aneurysm, Ruptured and Intracranial Aneurysm, sponsored by Seoul National University Hospital. Terminated at 3 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-07-25.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment

Why this study was terminated
Due to HEC supply issues at participating centers and low enrollment rate among eligible patients
Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Aneurysm, Ruptured
  • Intracranial Aneurysm

Keywords

  • aneurysms
  • embolization
  • rupture
03

In context

Aneurysm, Ruptured

29 studies on the registry are indexed under Aneurysm, Ruptured; 7 are open to participants now.

This study's enrollment of 68 is above the median of 33 across 16 interventional studies indexed under Aneurysm, Ruptured.

Browse Aneurysm, Ruptured studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • contrast allgery (+)
  • combined other intracranial lesions (tumor, moyamoya disease, cerebral vascular diseases)
  • ineligible for coil embolization
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
68 participants (actual)

Study arms

  • Experimental
    Second-generation hydrogel coil group

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

    Device: Coil embolization

  • Active comparator
    Bare platinum coil group

    Treatment using bare metal coil only for ruptured cerebral aneurysms

    Device: Coil embolization

Interventions

  • DeviceCoil embolization

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

06

What researchers measure

Primary outcomes

  1. any recurrence rate after treatment

    any recurrence rate at 12 months after coil embolization

    Time frame: during 12 months after coil embolization

Secondary outcomes

  1. rate of retreatment during 12 months follow-up period

    rate of retreatment during 12 months follow-up period

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

  2. packing density (%) after coil embolization

    packing density (%) after coil embolization

    Time frame: packing density (%) after coil embolization

  3. Procedural complication

    Procedural complication

    Time frame: during coil embolization

  4. delayed cerebral ischemia during 12-month follow-up period

    delayed cerebral ischemia during 12-month follow-up period

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

  5. good clinical outcome (mRS score ≤ 2) at 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

  6. rate of ventriculoperitoneal shunt during 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

  7. coil's ease of manipulation

    coil's ease of manipulation

    Time frame: during coil embolization

07

Study locations

3 sites
  • Chungnam National University Sejong Hospital
    Sejong, Chungcheongnam-do 30099, South Korea
  • Pusan National University Yangsan Hospital
    Yangsan, Gyeongsangnam-do 50612, South Korea
  • Seoul National University Bundang Hospital
    Seongnam-si, 13620, South Korea
08

References and documents

Publications

  • Ban SP, Kwon OK, Kim YD, Shim HS, Sung SB, Kim CH, Byoun HS. Comparison of second-generation hydrogel embolic coils and bare platinum coils in ruptured intracranial aneurysm treatment: A prospective, multicenter, randomized controlled study. Neurosurg Rev. 2026 Mar 18;49(1):289. doi: 10.1007/s10143-026-04212-1. PubMed 41844924 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04988503
Collaborators
Pusan National University Yangsan Hospital, Chungnam National University Sejong Hospital
Responsible party
Sponsor
First posted
Aug 3, 2021
Start date
Aug 30, 2021
Primary completion
Feb 28, 2025
Completion
Feb 28, 2025
Last update
Jul 25, 2025

Study contacts

O-Ki Kwon
principal investigator · Seoul National University Bundang Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion