ISRCTN72343080已完成未知
Aneurysm Embolization System (AES) for treatment of intracranial aneurysms: a post-market clinical follow-up
Covidien LP (USA)0 个研究点目标入组 63 人开始时间: 2011年6月10日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 63
研究概览
简要总结
2018 results in https://pubmed.ncbi.nlm.nih.gov/29669856/ (added 17/08/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Sex: male or female
- •2. Age: 18 to 75 years
- •3. Subject must be able to understand and be willing to sign an consent form
- •4. Subject must be considered a candidate for aneurysm coiling
- •5. Subject must be willing and able to participate in all aspects of the study and agree to comply with all study requirements for the duration of the study. This includes availability of reliable transportation and sufficient time to attend all follow-up visits
- •6. Subject is diagnosed with an intracranial aneurysm that has never been previously treated
- •7. The location, shape, neck size, overall aneurysm geometry and size must be consistent with the parameters set forth in the Instructions for Use ( IFU) for the LUNA™ AES in order to be acceptable for treatment
- •8. Subject must be of sufficient and stable medical health, as evaluated by the Prinicipal Investigator (PI)
排除标准
- •1. Subject has a fusiform aneurysm
- •2. The target aneurysm has been previously treated by surgical or endovascular means
- •3. Subject has symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease
- •4. Subject has pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer
- •5. Subject has renal and/or hepatic insufficiency
- •6. Subject has systemic infection in the body at the time of the LUNA™ AES procedure
- •7. Subject has history of neurovascular or neurologic disease that in the opinion of the Investigator would make them a poor candidate for the LUNA™ AES procedure
- •8. Subject is contraindicated for radiographic contrast media
- •9. Subject has severe coagulopathy (prothrombin time > 3 seconds over control or platelet count < 100,000) or is presently taking heparin, Coumadin® (warfarin), or other anticoagulants or other medications which impede coagulation or platelet aggregation
- •10. Subject has collagen vascular disease
- •11. Subject is undergoing chronic steroid therapy
- •12. Subject is undergoing immunosuppressive therapy
- •13. Subject has relative contraindication to angiography (e.g., serum creatinine level > 2.5 mg/dL)
- •14. Female subject who is pregnant (i.e., has a positive urine or blood pregnancy test prior to device implant), is suspected to be pregnant, is lactating or is of childbearing potential but refuses to use adequate contraception during the study
- •15. Subjects who have poorly controlled psychiatric disease including but not limited to manic-depressive disorder, schizophrenia, borderline personality disorder, depression or suicidal tendencies
- •16. Subject currently uses or has a history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than 4 alcoholic drinks per day)
- •17. Subject has participated in a clinical study with an investigational new drug, biological, or therapeutic device within 28 days prior to enrollment in this study, and does not agree to abstain from participation in other clinical trials of any kind during this study
- •18. The subject is unable to comply with trial procedures or protocol
- •19. Any co-morbid disease or condition expected to compromise survival or ability to complete follow-up assessments to 6 months
研究者
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