NL-OMON40251已完成不适用
Pilot study Clip design A pilot study about the first use of the Elana Clip design to create intracranial anastomoses - Pilot study Clip design
niversitair Medisch Centrum Utrecht0 个研究点目标入组 5 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patient is > 18 years old on the date he/she signed the informed consent ;Patient requires a temporary or permanent bypass in the brain as determined by the physician.;From preoperative considerations it seems that the patient can provide a suitable donor graft which does not seem to be varicose, obliterated or stenosed and which can be expected to have a diameter compatible with the proximal and distal target vessel with sufficient length to bridge the distance from the proximal to distal anastomosis;Target vessels should have an outer diameter of at least 3mm
排除标准
- •Patient cannot be without clopidogrel (Plavix®) for the surgery and through discharge ;Patient participates in another clinical investigation that could confound the evaluation of the Study device;Patient is allergic to Aspirin;Surgeon believes the patient is an unsuitable surgical candidate because of a poor general state of health, which would not permit the required operating and anesthesia time (add at an appropriate safety margin - at least 50% - to the expected surgery time in the assessment) or because of abnormal blood coagulation values
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