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Paraclinoid ANeurysm Prospectively Driven ObseRvational Analysis (PANDORA) Study

Conditions
Unruptured Aneurysm of Carotid Artery
Registration Number
NCT02553109
Lead Sponsor
Seoul National University Hospital
Brief Summary

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

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
682
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
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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
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Number of increased maximal diameter of enrolled paraclinoid aneurysms on follow up MRA or CTAwithin 5years after enrollment

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.

Number of rupture of enrolled paraclinoid aneurysmswithin 5years after enrollment

annual rupture rate

Secondary Outcome Measures
NameTimeMethod
Number of participants with worsened modified Rankin scale scorewithin 5years after enrollment

from 0(No symptom at all) to 6(Dead)

Treatment(due to growth or rupture) rate of enrolled aneurysmswithin 5years after enrollment
Mortality rate of enrolled patients(related to rupture of aneurysm or not)within 5years after enrollment

death due to ruptured aneurysm

Number of participants with worsened Karnofsky Performance Status scalewithin 5years after enrollment

from 0(Dead) to 100(Normal)

Trial Locations

Locations (8)

Seoul National University Hospital

🇰🇷

Seoul, Korea, Republic of

KangWon National University Hospital

🇰🇷

Chuncheon, Kangwon, Korea, Republic of

SMG-SNU Boramae Medical Center

🇰🇷

Seoul, Korea, Republic of

DongGuk University

🇰🇷

Ilsan, Kyungkido, Korea, Republic of

Gyeongsang National University Hospital

🇰🇷

Jinju, Gyeongsangnam-do, Korea, Republic of

Sungkyunkwan University Samsung Medical center

🇰🇷

Seoul, Kangnam, Korea, Republic of

Soonchunhyang University Hospital - Seoul

🇰🇷

Seoul, Korea, Republic of

Seoul National University Bundang Hospital

🇰🇷

Seongnam-si, Kyungkido, Korea, Republic of

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