Headache After Coil Embolization for Unruptured Intracranial Aneurysms

Headache Clinical Trial

Official title:

Comparison of Headache After Coil Embolization for Unruptured Intracranial Aneurysms (Standard Versus Stent-assisted): A Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03359252
• Other study ID #: B-1710/424-304
• Status: Completed
• Phase: N/A
• Start date: June 5, 2018
• Est. completion date: October 21, 2022

Study information

• Verified date: December 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: October 21, 2022
• Est. primary completion date: October 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Endovascular Procedures
• Headache
• Intracranial Aneurysm

Intervention

Procedure:
• non-stent assisted coiling
non-stent assisted coiling of unruptured intracranial aneurysm
• stent assisted coiling
stent assisted coiling of unruptured intracranial aneurysm

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

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. — View 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. — View 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. — View 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 Investigat — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	severity of headache after coil embolization between 2 arms	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	Duration of headache after coiling embolization after intervention	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
Secondary	characteristics of headache after coiling embolization between 2 arms	identify relationship between headache location and treated aneurysm or deployed stent	prior to intervention / immediate after procedures / postoperative days 3, 7, 14, 90 days