Headache After Coil Embolization for Unruptured Intracranial Aneurysms

NCT03359252 | Completed

• 1 other identifier: B-1710/424-304
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache; Aneurysm; Endovascular Procedures

Keywords

coil embolization; headache; stent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Duration of headache after coiling embolization after intervention

  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

  prior to intervention / immediate after procedures / postoperative days 3, 7, 14, 90 days

Study Arms (2)

non-stent assisted coiling

ACTIVE COMPARATOR

patients treated with non-stent assisted coiling of unruptured intracranial aneurysms

Procedure: non-stent assisted coiling

stent assisted coiling

EXPERIMENTAL

patients treated with stent assisted coiling of unruptured intracranial aneurysm

Procedure: stent assisted coiling

Interventions

non-stent assisted coiling PROCEDURE

non-stent assisted coiling of unruptured intracranial aneurysm

non-stent assisted coiling

stent assisted coiling PROCEDURE

stent assisted coiling of unruptured intracranial aneurysm

stent assisted coiling

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Seoul National University Bundang Hospital: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Related Publications (5)

• 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.

  PMID: 12867109 RESULT

• 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.

  PMID: 20671254 RESULT

• 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.

  PMID: 23771276 RESULT

• 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.

  PMID: 27991669 RESULT

• 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.

  PMID: 24801821 RESULT

MeSH Terms

Conditions

Headache; Aneurysm

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• O Kwon, M.D., Ph.D.

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: non-stent assisted coiling of unruptured intracranial aneurysms stent assisted coiling of unruptured intracranial aneurysms

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 2, 2017
• Study Start: June 5, 2018
• Primary Completion: October 21, 2022
• Study Completion: October 21, 2022
• Last Updated: October 25, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)