HeadacheNCT03359252
Headache After Coil Embolization for Unruptured Intracranial Aneurysms
A study testing non-stent assisted coiling and stent assisted coiling in people with Headache and Aneurysm, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Perform a prospective cohort study to compare the incidence and severity of headache between non-stent assisted coiling and stent assisted coiling of unruptured intracranial aneurysms. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Headache, Aneurysm, Endovascular Procedures
- What is being tested?
- non-stent assisted coiling and stent assisted coiling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Jun 2018to 21 Oct 2022
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with unruptured intracranial aneurysms
- patients over 20 years old
- patients who can communicate with each other
- patients who agreed to this study (with informed consent)
Who cannot join
- patients with recurrent aneurysms after coiling or clipping
- patients with allergic reaction to antiplatelets
- patients with high risks of hemorrhage
- patients with coagulopathy
- patients with thrombocytopenia (<100,000/mm3)
- patients with liver disease (> 100 of aspartate aminotransferase or alanine aminotransferase)
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- patients with renal disease (> 2mg/dL of serum creatinine)\
- patients with uncontrolled heart failure or angina
- patients with malignant tumor
- pregnant patients
- patients with past history that may associated with headache, including subarachnoid hemorrhage, head trauma, intracerebral hemorrhage, trigeminal neuralgia, arteriovenous malformation, brain tumor)
- Patients who are determined to be disqualified by researchers
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: Comparison of Headache After Coil Embolization for Unruptured Intracranial Aneurysms (Standard Versus Stent-assisted): A Prospective Cohort Study
Perform a prospective cohort study to compare the incidence and severity of headache between non-stent assisted coiling and stent assisted coiling of unruptured intracranial aneurysms.
Read the detailed description
severity of headache - assess with visual analogue scale characteristics of headache after stent deployment or simple coiling Duration of headache after intervention
- Conditions
- Headache, Aneurysm, Endovascular Procedures
- Being tested
- non-stent assisted coiling, stent assisted coiling
- Keywords
- coil embolization, headache, stent
- Medical subject headings
- Headache, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-stent assisted coilingProcedure or surgery
non-stent assisted coiling of unruptured intracranial aneurysm
stent assisted coilingProcedure or surgery
stent assisted coiling of unruptured intracranial aneurysm
| Study group | Role | What they receive |
|---|---|---|
| non-stent assisted coiling | Active comparator | patients treated with non-stent assisted coiling of unruptured intracranial aneurysms Receives: Procedure: non-stent assisted coiling |
| stent assisted coiling | Experimental | patients treated with stent assisted coiling of unruptured intracranial aneurysm Receives: Procedure: stent assisted coiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of headache after coil embolization between 2 arms
check change of severity of headache after coil embolization between 2 arms
Measured: prior to intervention / immediate after procedures / postoperative days 3, 7, 14, 90 days
Secondary outcomes (2)
Duration of headache after coiling embolization after intervention
check duration of headache after coil embolization
Measured: Measure the duration of time from when a headache occurs to when it disappears, assessed up to 3 months
characteristics of headache after coiling embolization between 2 arms
identify relationship between headache location and treated aneurysm or deployed stent
Measured: prior to intervention / immediate after procedures / postoperative days 3, 7, 14, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start5 Jun 2018
- Primary completion21 Oct 2022
- Study completion21 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HeadacheStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- non-stent assisted coiling of unruptured intracranial aneurysms stent assisted coiling of unruptured intracranial aneurysms
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Responsible party
- Sponsor
- Investigators
- O Kwon, M.D., Ph.D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03359252
- Sponsor's protocol ID
- B-1710/424-304
- Status last verified
- Dec 2021
- First submitted
- 27 Nov 2017
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wiebers DO, Whisnant JP, Huston J 3rd, Meissner I, Brown RD Jr, Piepgras DG, Forbes GS, Thielen K, Nichols D, O'Fallon WM, Peacock J, Jaeger L, Kassell NF, Kongable-Beckman GL, Torner JC; International Study of Unruptured Intracranial Aneurysms Investigators. Unruptured intracranial aneurysms: natural history, clinical outcome, and risks of surgical and endovascular treatment. Lancet. 2003 Jul 12;362(9378):103-10. doi: 10.1016/s0140-6736(03)13860-3.
PubMed 12867109Sonobe M, Yamazaki T, Yonekura M, Kikuchi H. Small unruptured intracranial aneurysm verification study: SUAVe study, Japan. Stroke. 2010 Sep;41(9):1969-77. doi: 10.1161/STROKEAHA.110.585059. Epub 2010 Jul 29.
PubMed 20671254Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.
PubMed 23771276Zhang L, Wu X, Di H, Feng T, Wang Y, Wang J, Cao X, Li B, Liu R, Yu S. Characteristics of Headache After an Intracranial Endovascular Procedure: A Prospective Observational Study. Headache. 2017 Mar;57(3):391-399. doi: 10.1111/head.13006. Epub 2016 Dec 19.
PubMed 27991669Choi KS, Lee JH, Yi HJ, Chun HJ, Lee YJ, Kim DW. Incidence and risk factors of postoperative headache after endovascular coil embolization of unruptured intracranial aneurysms. Acta Neurochir (Wien). 2014 Jul;156(7):1281-7. doi: 10.1007/s00701-014-2095-8. Epub 2014 May 7.
PubMed 24801821
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Headache After Coil Embolization for Unruptured Intracranial Aneurysms (Standard Versus Stent-assisted): A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03359252
- Acronym / sponsor ID
- B-1710/424-304
- Conditions
- Headache, Aneurysm, Endovascular Procedures
- Keywords
- coil embolization, headache, stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 21 Oct 2022 (actual)
- Study completion
- 21 Oct 2022 (actual)
- First posted
- 2 Dec 2017 (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.
Perform a prospective cohort study to compare the incidence and severity of headache between non-stent assisted coiling and stent assisted coiling of unruptured intracranial aneurysms.
Detailed description
severity of headache - assess with visual analogue scale characteristics of headache after stent deployment or simple coiling Duration of headache after intervention
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- non-stent assisted coiling of unruptured intracranial aneurysms stent assisted coiling of unruptured intracranial aneurysms
| Arm | Type | Receives |
|---|---|---|
| non-stent assisted coiling | Active comparator | Procedure: non-stent assisted coilingpatients treated with non-stent assisted coiling of unruptured intracranial aneurysms |
| stent assisted coiling | Experimental | Procedure: stent assisted coilingpatients treated with stent assisted coiling of unruptured intracranial aneurysm |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with unruptured intracranial aneurysms
- patients over 20 years old
- patients who can communicate with each other
- patients who agreed to this study (with informed consent)
Key exclusion criteria (12 listed)
- patients with recurrent aneurysms after coiling or clipping
- patients with allergic reaction to antiplatelets
- patients with high risks of hemorrhage
- patients with coagulopathy
- patients with thrombocytopenia (<100,000/mm3)
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 |
|---|---|---|
| non-stent assisted coilingnon-stent assisted coiling of unruptured intracranial aneurysm | Procedure or surgery | non-stent assisted coiling |
| stent assisted coilingstent assisted coiling of unruptured intracranial aneurysm | Procedure or surgery | stent assisted coiling |
Primary outcome
severity of headache after coil embolization between 2 arms
Time frame: prior to intervention / immediate after procedures / postoperative days 3, 7, 14, 90 days
check change of severity of headache after coil embolization between 2 arms
2 secondary outcomes
Duration of headache after coiling embolization after intervention
Time frame: Measure the duration of time from when a headache occurs to when it disappears, assessed up to 3 months
characteristics of headache after coiling embolization between 2 arms
Time frame: prior to intervention / immediate after procedures / postoperative days 3, 7, 14, 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Results publication: PubMed 12867109Wiebers DO, Whisnant JP, Huston J 3rd, Meissner I, Brown RD Jr, Piepgras DG, Forbes GS, Thielen K, Nichols D, O'Fallon WM, Peacock J, Jaeger L, Kassell NF, Kongable-Beckman GL, Torner JC; International Study of Unruptured Intracranial Aneurysms Investigators. Unruptured intracranial aneurysms: natural history, clinical outcome, and risks of surgical and endovascular treatment. Lancet. 2003 Jul 12;362(9378):103-10. doi: 10.1016/s0140-6736(03)13860-3.
- Results publication: PubMed 20671254Sonobe M, Yamazaki T, Yonekura M, Kikuchi H. Small unruptured intracranial aneurysm verification study: SUAVe study, Japan. Stroke. 2010 Sep;41(9):1969-77. doi: 10.1161/STROKEAHA.110.585059. Epub 2010 Jul 29.
- Results publication: PubMed 23771276Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.
- Results publication: PubMed 27991669Zhang L, Wu X, Di H, Feng T, Wang Y, Wang J, Cao X, Li B, Liu R, Yu S. Characteristics of Headache After an Intracranial Endovascular Procedure: A Prospective Observational Study. Headache. 2017 Mar;57(3):391-399. doi: 10.1111/head.13006. Epub 2016 Dec 19.
- Results publication: PubMed 24801821Choi KS, Lee JH, Yi HJ, Chun HJ, Lee YJ, Kim DW. Incidence and risk factors of postoperative headache after endovascular coil embolization of unruptured intracranial aneurysms. Acta Neurochir (Wien). 2014 Jul;156(7):1281-7. doi: 10.1007/s00701-014-2095-8. Epub 2014 May 7.
- 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 Kwon, M.D., Ph.D. principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-stent assisted coiling and stent assisted coiling in people with Headache and Aneurysm, run by Seoul National University Hospital at 1 site 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 4 inclusion and 12 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: finished, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
severity of headache after coil embolization between 2 arms (time frame: prior to intervention / immediate after procedures / postoperative days 3, 7, 14, 90 days). 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 NCT03359252, which also lists 5 linked publications.
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 Oct 2022; AzTrials last refreshed its copy on 1 Nov 2026.