Paraclinoid ANeurysm Prospectively Driven ObseRvational Analysis (PANDORA) Study

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02553109
• Collaborator: Seoul National University Bundang Hospital (Other), SMG-SNU Boramae Medical Center (Other), DongGuk University (Other), Inje University (Other), Jeju National University Hospital (Other), KangWon National University Hospital (Other), Gyeongsang National University Hospital (Other), Soonchunhyang University Hospital (Other), Samsung Medical Center (Other), Asan Medical Center (Other)
• Enrollment: 682
• Locations: 8
• Duration (Months): 107
• Patients Per Site: 85.3
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Unruptured Aneurysm of Carotid Artery

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.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 682 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Risk of Rupture or Growth in Patients With Small Unruptured Paraclinoid Aneurysm: Paraclinoid ANeurysm Prospectively Driven ObseRvational Analysis (PANDORA) Study
• Study Start Date: Jan 1, 2015
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. Number of rupture of enrolled paraclinoid aneurysms [within 5years after enrollment]

   annual rupture rate

Secondary Outcome Measures

1. Mortality rate of enrolled patients(related to rupture of aneurysm or not) [within 5years after enrollment]

   death due to ruptured aneurysm

2. Number of participants with worsened modified Rankin scale score [within 5years after enrollment]

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

3. Number of participants with worsened Karnofsky Performance Status scale [within 5years after enrollment]

   from 0(Dead) to 100(Normal)

4. Treatment(due to growth or rupture) rate of enrolled aneurysms [within 5years after enrollment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gyeongsang National University Hospital	Jinju	Gyeongsangnam-do	Korea, Republic of
2	Sungkyunkwan University Samsung Medical center	Seoul	Kangnam	Korea, Republic of	06351
3	KangWon National University Hospital	Chuncheon	Kangwon	Korea, Republic of
4	DongGuk University	Ilsan	Kyungkido	Korea, Republic of
5	Seoul National University Bundang Hospital	Seongnam-si	Kyungkido	Korea, Republic of	13620
6	Seoul National University Hospital	Seoul		Korea, Republic of
7	SMG-SNU Boramae Medical Center	Seoul		Korea, Republic of
8	Soonchunhyang University Hospital - Seoul	Seoul		Korea, Republic of

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Jeong Eun Kim, MD. PhD., Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Jeong Eun Kim, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT02553109
• Other Study ID Numbers: SNUH-001
• First Posted: Sep 17, 2015
• Last Update Posted: May 12, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Jeong Eun Kim, Professor, Seoul National University Hospital: small paraclinoid
• Additional relevant MeSH terms: Aneurysm

Study Results

No Results Posted as of May 12, 2022