Paraclinoid ANeurysm Prospectively Driven ObseRvational Analysis (PANDORA) Study

NCT02553109 | Unknown DMC

• 1 other identifier: SNUH-001
• Study Type: observational
• Target: 682
• Locations: 1 country
• Sites: 8

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.

Conditions

Unruptured Aneurysm of Carotid Artery

Keywords

small paraclinoid

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Mortality rate of enrolled patients(related to rupture of aneurysm or not)

  within 5years after enrollment

• Number of participants with worsened modified Rankin scale score

  within 5years after enrollment

• Number of participants with worsened Karnofsky Performance Status scale

  within 5years after enrollment

• Treatment(due to growth or rupture) rate of enrolled aneurysms

  within 5years after enrollment

Study Arms (1)

small unruptured paraclinoid aneurysm

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.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Invastigators defined the cohort population as adults( more than 20 years old) with newly diagnosed small (less than 5mm) unruptured paraclinoid aneurysm who agree to participate.

You may qualify if:

• Patients with newly diagnosed small unruptured paraclinoid aneurysms who agreed to participate.
• years 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Seoul National University Bundang Hospital: collaborator
• SMG-SNU Boramae Medical Center: collaborator
• DongGuk University: collaborator
• Inje University: collaborator
• Jeju National University Hospital: collaborator
• KangWon National University Hospital: collaborator
• Gyeongsang National University Hospital: collaborator
• Soonchunhyang University Hospital: collaborator
• Samsung Medical Center: collaborator
• Asan Medical Center: collaborator

Study Sites (8)

KangWon National University Hospital

Chuncheon, Gangwon-do, South Korea

Location

Gyeongsang National University Hospital

Jinju, Gyeongsangnam-do, South Korea

Location

Sungkyunkwan University Samsung Medical center

Seoul, Kangnam, 06351, South Korea

Location

DongGuk University

Ilsan, Kyungkido, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Kyungkido, 13620, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

SMG-SNU Boramae Medical Center

Seoul, South Korea

Location

Soonchunhyang University Hospital - Seoul

Seoul, South Korea

Location

Related Publications (6)

• Jeon JS, Ahn JH, Huh W, Son YJ, Bang JS, Kang HS, Sohn CH, Oh CW, Kwon OK, Kim JE. A retrospective analysis on the natural history of incidental small paraclinoid unruptured aneurysm. J Neurol Neurosurg Psychiatry. 2014 Mar;85(3):289-94. doi: 10.1136/jnnp-2013-305019. Epub 2013 Jun 18.

  PMID: 23781005 BACKGROUND

• Barami K, Hernandez VS, Diaz FG, Guthikonda M. Paraclinoid Carotid Aneurysms: Surgical Management, Complications, and Outcome Based on a New Classification Scheme. Skull Base. 2003 Feb;13(1):31-41. doi: 10.1055/s-2003-820555.

  PMID: 15912157 BACKGROUND

• Juvela S, Poussa K, Lehto H, Porras M. Natural history of unruptured intracranial aneurysms: a long-term follow-up study. Stroke. 2013 Sep;44(9):2414-21. doi: 10.1161/STROKEAHA.113.001838. Epub 2013 Jul 18.

  PMID: 23868274 BACKGROUND

• Sonobe M, Yamazaki T, Yonekura M, Kikuchi H. Small unruptured intracranial aneurysm verification study: SUAVe study, Japan. Stroke. 2010 Sep;41(9):1969-77. doi: 10.1161/STROKEAHA.110.585059. Epub 2010 Jul 29.

  PMID: 20671254 BACKGROUND

• UCAS Japan Investigators; Morita A, Kirino T, Hashi K, Aoki N, Fukuhara S, Hashimoto N, Nakayama T, Sakai M, Teramoto A, Tominari S, Yoshimoto T. The natural course of unruptured cerebral aneurysms in a Japanese cohort. N Engl J Med. 2012 Jun 28;366(26):2474-82. doi: 10.1056/NEJMoa1113260.

  PMID: 22738097 BACKGROUND

• Wiebers DO, Whisnant JP, Huston J 3rd, Meissner I, Brown RD Jr, Piepgras DG, Forbes GS, Thielen K, Nichols D, O'Fallon WM, Peacock J, Jaeger L, Kassell NF, Kongable-Beckman GL, Torner JC; International Study of Unruptured Intracranial Aneurysms Investigators. Unruptured intracranial aneurysms: natural history, clinical outcome, and risks of surgical and endovascular treatment. Lancet. 2003 Jul 12;362(9378):103-10. doi: 10.1016/s0140-6736(03)13860-3.

  PMID: 12867109 BACKGROUND

Study Officials

• Jeong Eun Kim, MD. PhD.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 20, 2015
• First Posted: September 17, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: May 12, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (8)