Unruptured Aneurysm of Carotid Artery Clinical Trial
— PANDORAOfficial title:
The Risk of Rupture or Growth in Patients With Small Unruptured Paraclinoid Aneurysm: Paraclinoid ANeurysm Prospectively Driven ObseRvational Analysis (PANDORA) Study
| Verified date | May 2022 |
| Source | Seoul National University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Active, not recruiting |
| Enrollment | 682 |
| Est. completion date | December 2023 |
| Est. primary completion date | December 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | KangWon National University Hospital | Chuncheon | Kangwon |
| Korea, Republic of | DongGuk University | Ilsan | Kyungkido |
| Korea, Republic of | Gyeongsang National University Hospital | Jinju | Gyeongsangnam-do |
| Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si | Kyungkido |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Korea, Republic of | SMG-SNU Boramae Medical Center | Seoul | |
| Korea, Republic of | Soonchunhyang University Hospital - Seoul | Seoul | |
| Korea, Republic of | Sungkyunkwan University Samsung Medical center | Seoul | Kangnam |
| Lead Sponsor | Collaborator |
|---|---|
| Seoul National University Hospital | Asan Medical Center, DongGuk University, Gyeongsang National University Hospital, Inje University, Jeju National University Hospital, KangWon National University Hospital, Samsung Medical Center, Seoul National University Bundang Hospital, SMG-SNU Boramae Medical Center, Soonchunhyang University Hospital |
Korea, Republic of,
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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. — View Citation
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | Number of rupture of enrolled paraclinoid aneurysms | annual rupture rate | within 5years after enrollment | |
| Secondary | Mortality rate of enrolled patients(related to rupture of aneurysm or not) | death due to ruptured aneurysm | within 5years after enrollment | |
| Secondary | Number of participants with worsened modified Rankin scale score | from 0(No symptom at all) to 6(Dead) | within 5years after enrollment | |
| Secondary | Number of participants with worsened Karnofsky Performance Status scale | from 0(Dead) to 100(Normal) | within 5years after enrollment | |
| Secondary | Treatment(due to growth or rupture) rate of enrolled aneurysms | within 5years after enrollment |