Headache After Coil Embolization for Unruptured Intracranial Aneurysms

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

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

Conditions
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Headache, Aneurysm, Endovascular Procedures

Intervention / Treatment
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* Procedure: non-stent assisted coiling
* Procedure: stent assisted coiling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: non-stent assisted coiling of unruptured intracranial aneurysms stent assisted coiling of unruptured intracranial aneurysms
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: non-stent assisted coiling<br>patients treated with non-stent assisted coiling of unruptured intracranial aneurysms | Procedure: non-stent assisted coiling<br>* non-stent assisted coiling of unruptured intracranial aneurysm<br>|
| Experimental: stent assisted coiling<br>patients treated with stent assisted coiling of unruptured intracranial aneurysm | Procedure: stent assisted coiling<br>* stent assisted coiling of unruptured intracranial aneurysm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stent, coil embolization, headache