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
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of increased maximal diameter of enrolled paraclinoid aneurysms on follow up MRA or CTA within 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 aneurysms within 5years after enrollment annual rupture rate
- Secondary Outcome Measures
Name Time Method Number of participants with worsened modified Rankin scale score within 5years after enrollment from 0(No symptom at all) to 6(Dead)
Treatment(due to growth or rupture) rate of enrolled aneurysms within 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 scale within 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