Paraclinoid ANeurysm Prospectively Driven ObseRvational Analysis (PANDORA) Study

Seoul National University Hospital682 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

682

Conditions

Unruptured Aneurysm of Carotid Artery

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (8)

KangWon National University Hospital

Chuncheon, Gangwon-do, South Korea

Gyeongsang National University Hospital

Jinju, Gyeongsangnam-do, South Korea

Sungkyunkwan University Samsung Medical center

Seoul, Kangnam, South Korea

DongGuk University

Ilsan, Kyungkido, South Korea

Outcomes

Primary Outcomes

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.