Aneurysm, RupturedNCT04988503
Bare Platinum Coils Versus Second-generation Hydrocoils
A study testing Coil embolization in people with Aneurysm, Ruptured and Intracranial Aneurysm, run by Seoul National University Hospital at 3 sites in South Korea.
Trial summary
Comparison of clinical and radiological outcomes between bare platinum coil group and second-generation hydrogel coils for treatment of ruptured intracranial aneurysms. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Aneurysm, Ruptured, Intracranial Aneurysm
- What is being tested?
- Coil embolization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 30 Aug 2021to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- contrast allgery (+)
- combined other intracranial lesions (tumor, moyamoya disease, cerebral vascular diseases)
- ineligible for coil embolization
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Chungnam National University Sejong Hospital
Sejong, Chungcheongnam-do, 30099
Seoul National University Bundang Hospital
Seongnam-si, 13620
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612
About this study
Official title: Bare Platinum Coils Versus Second-generation Hydrocoils for the Endovascular Treatment of Ruptured Intracranial Aneurysms: a Randomized Controlled Study
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.
- Conditions
- Aneurysm, Ruptured, Intracranial Aneurysm
- Being tested
- Coil embolization
- Keywords
- aneurysms, embolization, rupture
- Medical subject headings
- Aneurysm, Ruptured, Intracranial Aneurysm, Aneurysm, Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coil embolizationDevice
coil embolization for ruptured intracranial aneurysm with bare platinum coils or second-generation hydrogel coils
| Study group | Role | What they receive |
|---|---|---|
| Second-generation hydrogel coil group | Experimental | Treatment using second-generation hydrogel coils (had to constitute > 50% of the total coil length) for ruptured cerebral aneurysms Receives: Device: Coil embolization |
| Bare platinum coil group | Active comparator | Treatment using bare metal coil only for ruptured cerebral aneurysms Receives: Device: Coil embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
any recurrence rate after treatment
any recurrence rate at 12 months after coil embolization
Measured: during 12 months after coil embolization
Secondary outcomes (7)
rate of retreatment during 12 months follow-up period
rate of retreatment during 12 months follow-up period
Measured: rate of retreatment during 12 months follow-up period
packing density (%) after coil embolization
packing density (%) after coil embolization
Measured: packing density (%) after coil embolization
Procedural complication
Procedural complication
Measured: during coil embolization
delayed cerebral ischemia during 12-month follow-up period
delayed cerebral ischemia during 12-month follow-up period
Measured: 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
Measured: 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
Measured: rate of ventriculoperitoneal shunt during 12-month follow-up period
coil's ease of manipulation
coil's ease of manipulation
Measured: during coil embolization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start30 Aug 2021
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Why it stopped: Due to HEC supply issues at participating centers and low enrollment rate among eligible patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aneurysm, RupturedStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- bare platinum coils group versus second-generation hydrogel coil group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pusan National University Yangsan Hospital, Chungnam National University Sejong Hospital
- Responsible party
- Sponsor
- Investigators
- O-Ki Kwon, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988503
- Sponsor's protocol ID
- B-2012/652-002
- Status last verified
- May 2025
- First submitted
- 23 Jul 2021
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bare Platinum Coils Versus Second-generation Hydrocoils for the Endovascular Treatment of Ruptured Intracranial Aneurysms: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04988503
- Acronym / sponsor ID
- B-2012/652-002
- Conditions
- Aneurysm, Ruptured, Intracranial Aneurysm
- Keywords
- aneurysms, embolization, rupture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to HEC supply issues at participating centers and low enrollment rate among eligible patients
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Pusan National University Yangsan Hospital, Chungnam National University Sejong Hospital
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- bare platinum coils group versus second-generation hydrogel coil group
| Arm | Type | Receives |
|---|---|---|
| Second-generation hydrogel coil group | Experimental | Device: Coil embolizationTreatment using second-generation hydrogel coils (had to constitute > 50% of the total coil length) for ruptured cerebral aneurysms |
| Bare platinum coil group | Active comparator | Device: Coil embolizationTreatment using bare metal coil only for ruptured cerebral aneurysms |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- contrast allgery (+)
- combined other intracranial lesions (tumor, moyamoya disease, cerebral vascular diseases)
- ineligible for coil embolization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coil embolizationcoil embolization for ruptured intracranial aneurysm with bare platinum coils or second-generation hydrogel coils | Device | Bare platinum coil group, Second-generation hydrogel coil group |
Primary outcome
any recurrence rate after treatment
Time frame: during 12 months after coil embolization
any recurrence rate at 12 months after coil embolization
7 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
Time frame: during coil embolization
Results and safety
The study was stopped early (reason given: Due to HEC supply issues at participating centers and low enrollment rate among eligible patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Derived from this study: PubMed 41844924Ban 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
O-Ki Kwon principal investigator
Seoul National University Bundang Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coil embolization in people with Aneurysm, Ruptured and Intracranial Aneurysm, run by Seoul National University Hospital at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to HEC supply issues at participating centers and low enrollment rate among eligible patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
any recurrence rate after treatment (time frame: during 12 months after coil embolization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04988503, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.