Paraclinoid ANeurysm Prospectively Driven ObseRvational Analysis (PANDORA) Study

Study Overview
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Brief Summary
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The optimal consensus concerning treatment of incidental small paraclinoid unruptured intracranial aneurysms (UIAs) remains controversial. The aim of this prospective study is to reveal the natural history of small paraclinoid UIAs with the goal of informing the treatment plan.

Detailed Description
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A prospective observational study will be conducted in 13 Korean centers enrolling a consecutive series of 645 patients with small paraclinoid unruptured intracranial aneurysms (UIAs) from 2015 to 2017. The investigators defined the cohort population as adults(20 years old or more) with small (less than 5mm) unruptured paraclinoid aneurysm. To determine the growth rate and risk factors, the angiographic features based on MRA or CTA(ex) size, arterial relationship, multiplicity)and the clinical characteristics (ex) age, hypertension (HTN), diabetes mellitus(DM), Hyperlipidemia, smoking) are recorded at initial visit, 1 year, 2years, 3years, and 5years. The cumulative risk and the risk factors of aneurysmal rupture and growth will be analysed.

Official Title
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The Risk of Rupture or Growth in Patients With Small Unruptured Paraclinoid Aneurysm: Paraclinoid ANeurysm Prospectively Driven ObseRvational Analysis (PANDORA) Study

Conditions
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Unruptured Aneurysm of Carotid Artery

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with newly diagnosed small unruptured paraclinoid aneurysms who agreed to participate. 20years old or more less than 5mm in maximum diameter neurological status of patients should be satisfied with less than modified Rankin score 2 or more than 70 in Karnofsky performance score Exclusion Criteria: patients had previous subarachnoid hemorrhage that could be related to the rupture of paraclinoid aneurysm. traumatic, infectious or dissecting aneurysms fusiform aneurysms aneurysms that related to other vascular disease or brain tumor aneurysm that associated with the atherosclerotic change of a parent artery

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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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| small unruptured paraclinoid aneurysm<br>Patients with newly diagnosed, small (less than 5mm) unruptured paraclinoid aneurysms who will visit one of the study centers during the period from January 2015 to February 2017. Patients would be eligible for enrollment if they were 20 years of age or older and had an unruptured paraclinoid aneurysm that is less than 5 mm in the largest dimension. All patients who would visit a study center during the enrollment period and meet these criteria will be asked to join the study. The cohort will consists of patients who agree to participate. Target population of this study is 645 aneurysms. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of increased maximal diameter of enrolled paraclinoid aneurysms on follow up MRA or CTA | If, the maximal diameter(in mm) of aneurysm which is measured by 1 neurosurgeon and 1 neuroradiologist on follow up MRA or CTA (1,2,3,5 year follow up) is 1.5 times bigger than on initial MRA or CTA, investigators will decide that the aneurysm is increased. | within 5years after enrollment | 
| Number of rupture of enrolled paraclinoid aneurysms | annual rupture rate | within 5years after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate of enrolled patients(related to rupture of aneurysm or not) | death due to ruptured aneurysm | within 5years after enrollment | 
| Number of participants with worsened modified Rankin scale score | from 0(No symptom at all) to 6(Dead) | within 5years after enrollment | 
| Number of participants with worsened Karnofsky Performance Status scale | from 0(Dead) to 100(Normal) | within 5years after enrollment | 
| Treatment(due to growth or rupture) rate of enrolled aneurysms |  | within 5years after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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small paraclinoid