- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03359252
Headache After Coil Embolization for Unruptured Intracranial Aneurysms
October 23, 2022 updated by: Seoul National University Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
190
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gyeonggi-do
-
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
- Seoul National University Bundang Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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)
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: non-stent assisted coiling
patients treated with non-stent assisted coiling of unruptured intracranial aneurysms
|
non-stent assisted coiling of unruptured intracranial aneurysm
|
Experimental: stent assisted coiling
patients treated with stent assisted coiling of unruptured intracranial aneurysm
|
stent assisted coiling of unruptured intracranial aneurysm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
prior to intervention / immediate after procedures / postoperative days 3, 7, 14, 90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
check duration of headache after coil embolization
|
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
|
identify relationship between headache location and treated aneurysm or deployed stent
|
prior to intervention / immediate after procedures / postoperative days 3, 7, 14, 90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: O Kwon, M.D., Ph.D., Seoul National University Bundang Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Sonobe 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.
- Headache 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.
- Zhang 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.
- Choi 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. Erratum In: Acta Neurochir (Wien). 2014 Sep;156(9):1829.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 5, 2018
Primary Completion (Actual)
October 21, 2022
Study Completion (Actual)
October 21, 2022
Study Registration Dates
First Submitted
November 27, 2017
First Submitted That Met QC Criteria
November 27, 2017
First Posted (Actual)
December 2, 2017
Study Record Updates
Last Update Posted (Actual)
October 25, 2022
Last Update Submitted That Met QC Criteria
October 23, 2022
Last Verified
December 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-1710/424-304
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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