Paraclinoid ANeurysm Prospectively Driven ObseRvational Analysis (PANDORA) Study

Seoul National University

Status: Unknown

Conditions: Unruptured Aneurysm of Carotid Artery

Study type: Observational

Funder types: Other

Identifiers

NCT02553109

SNUH-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 682 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

682 participants in 1 patient group

small unruptured paraclinoid aneurysm

Description:

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.