Aneurysm, Endovascular Procedures, Headache
Conditions
Keywords
coil embolization, headache, stent
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
Interventions
PROCEDUREnon-stent assisted coiling
non-stent assisted coiling of unruptured intracranial aneurysm
PROCEDUREstent assisted coiling
stent assisted coiling of unruptured intracranial aneurysm
Sponsors
Seoul National University Bundang Hospital
Seoul National University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
non-stent assisted coiling of unruptured intracranial aneurysms stent assisted coiling of unruptured intracranial aneurysms
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed