A prospective study to evaluate the safety and performance of a shape memory polymer foam embolization device for arterial or venous embolization of the peripheral vasculature system by assessing rates of serious adverse events and unanticipated serious adverse device effects from the day of procedure through 30 days post-procedure.

Shape Memory Medical Inc0 个研究点目标入组 11 人开始时间: 2017年6月20日最近更新: 2020年5月4日

适应症

试验速览

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•Study Participant is greater than or equal to 18 years of age and less than or equal to 75 years of age;
•Study Participant is considered a candidate for arterial or venous embolization of the peripheral vasculature;
•Study Participant has a target vessel >2 mm and <9 mm in diameter, measured during angiographic imaging.

•Study Participant has an inability to provide written informed consent;
•Study Participant has inappropriate anatomy of the vasculature for the safe access and/or the deployment of the study device,
•Study Participant has known hypersensitivity or contraindication to nickel or nitinol;
•Study Participant has a condition that inhibits radiographic visualization during the implantation procedure;
•Study Participant has a history of allergy to contrast medium that cannot be managed medically;
•Study Participant has an uncontrolled co-morbid medical condition that would adversely affect participation in the Study;
•Study Participant is pregnant or a lactating female.

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