A prospective, non-randomised, open-label, multicenter safety study of Neucrylate AN™ Liquid Embolic System for the treatment of cerebral berry aneurysms

Valor Medical Inc. (USA)0 个研究点目标入组 40 人开始时间: 2009年10月6日最近更新: 2017年6月5日

试验速览

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•1. Subject must be a male or female >=18 years of age (i.e., not children as defined by local law or regulation)
•2. Subject must have a cerebral aneurysm and neurological status
•3. Subject must be considered by the physician to be available for subsequent visits
•4. Subject must be able to comply with all aspects of the treatment and evaluation schedule over 7 months duration
•5. Subject must sign and date an EC/IRB-approved written informed consent prior to initiation of any study procedures, including screening procedures (if unable to sign for self, where applicable, legal representative may do so)
•6. Subject has not previously been treated for aneurysm or subarachnoid haemorrhage

•1. Subject is female and pregnant, or breastfeeding
•2. Subject has a known allergy to cyanoacrylates
•3. Subject has a significant bleeding disorder
•4. Subject has known hypersensitivity to any component of the study device or procedural materials
•5. Subject is concurrently involved in another investigational study
•6. Subject has received any investigational product within 30 days prior to entry into this trial
•7. Subject has an acute life-threatening illness other than the neurological disease to be treated in this trial
•8. Inability to obtain valid informed consent (consent may be given by legal representative, where applicable)
•9. Subject has a life expectancy of less than 1 year due to other illness or condition (in addition to aneurysm)
•10. The subject requires treatment for fusiform or lateral aneurysm

发起方

Valor Medical Inc. (USA)