Headache After Coil Embolization for Unruptured Intracranial Aneurysms

Sponsor

Seoul National University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03359252

Collaborator

Seoul National University Bundang Hospital (Other)

190

Enrollment

Location

Arms

54.9

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Headache Aneurysm Endovascular Procedures	Procedure: non-stent assisted coiling Procedure: stent assisted coiling	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

190 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

non-stent assisted coiling of unruptured intracranial aneurysms stent assisted coiling of unruptured intracranial aneurysmsnon-stent assisted coiling of unruptured intracranial aneurysms stent assisted coiling of unruptured intracranial aneurysms

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jun 5, 2018

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: non-stent assisted coiling patients treated with non-stent assisted coiling of unruptured intracranial aneurysms	Procedure: non-stent assisted coiling non-stent assisted coiling of unruptured intracranial aneurysm
Experimental: stent assisted coiling patients treated with stent assisted coiling of unruptured intracranial aneurysm	Procedure: stent assisted coiling stent assisted coiling of unruptured intracranial aneurysm

Arm

Intervention/Treatment

Active Comparator: non-stent assisted coiling

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

Procedure: non-stent assisted coiling

non-stent assisted coiling of unruptured intracranial aneurysm

Experimental: stent assisted coiling

patients treated with stent assisted coiling of unruptured intracranial aneurysm

Procedure: stent assisted coiling

stent assisted coiling of unruptured intracranial aneurysm

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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