Headache After Coil Embolization for Unruptured Intracranial Aneurysms

Not Applicable

Completed

• Conditions: Headache; Aneurysm; Endovascular Procedures
• Interventions: Procedure: non-stent assisted coiling; Procedure: stent assisted coiling

• Registration Number: NCT03359252
• Lead Sponsor: Seoul National University Hospital

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

Study Timeline

• Study First Submitted: 2017-11-27
• Study First Submitted QC: 2017-11-27
• Study First Posted: 2017-12-02
• Study Start: 2018-06-05
• Status Verified: 2021-12
• Primary Completion: 2022-10-21
• Study Completion: 2022-10-21
• Last Update Submitted: 2022-10-23
• Last Update Posted: 2022-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non-stent assisted coiling	non-stent assisted coiling	patients treated with non-stent assisted coiling of unruptured intracranial aneurysms
stent assisted coiling	stent assisted coiling	patients treated with stent assisted coiling of unruptured intracranial aneurysm

Primary Outcome Measures

Name	Time	Method
severity of headache after coil embolization between 2 arms	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

Secondary Outcome Measures

Name	Time	Method
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	check duration of headache after coil embolization
characteristics of headache after coiling embolization between 2 arms	prior to intervention / immediate after procedures / postoperative days 3, 7, 14, 90 days	identify relationship between headache location and treated aneurysm or deployed stent

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of