Clinical trial NCT03359252: Headache After Coil Embolization for Unruptured Intracranial Aneurysms
Official title: Comparison of Headache After Coil Embolization for Unruptured Intracranial Aneurysms (Standard Versus Stent-assisted): A Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache
Aneurysm
Endovascular Procedures
Keywords: coil embolization
headache
stent
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
First posted: 2017-12-02
Enrollment: 190
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: non-stent assisted coiling of unruptured intracranial aneurysms stent assisted coiling of unruptured intracranial aneurysms
Primary purpose: OTHER

Brief 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.

Detailed description: severity of headache - assess with visual analogue scale characteristics of headache after stent deployment or simple coiling Duration of headache after intervention

Eligibility criteria: 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

Primary outcomes:
measure: severity of headache after coil embolization between 2 arms
timeFrame: prior to intervention / immediate after procedures / postoperative days 3, 7, 14, 90 days
Secondary outcomes:
measure: Duration of headache after coiling embolization after intervention
timeFrame: Measure the duration of time from when a headache occurs to when it disappears, assessed up to 3 months
measure: characteristics of headache after coiling embolization between 2 arms
timeFrame: prior to intervention / immediate after procedures / postoperative days 3, 7, 14, 90 days
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: O Kwon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.