Aneurysm Treatment using the HeliFX Aortic Securement System Global Registry

Director Clinical AffairsAptus Endosystems, Inc.0 个研究点目标入组 2,000 人开始时间: 2012年12月19日最近更新: 2024年8月19日

适应症

试验速览

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•1.Subjects with asymptomatic, symptomatic, or ruptured abdominal aortic aneurysms
•2.Subject = 18 years old
•3.Subject has provided written informed consent, either before or less than or equal to 30 days after the index procedure
•4.Subject is willing and able to comply with standard of care follow-up evaluations
•5.Subject has a previously implanted endograft (Revision Group), or will be undergoing repair (Primary Group), with one of the following abdominal aortic aneurysm endograft devices:
•Cook Zenith
•Gore Excluder
•Medtronic AneuRx
•Medtronic Talent
•Medtronic Endurant
•Any additional third party AAA endograft device that is commercially available and listed as compatible with the HeliFX system in the Instructions for Use
•6.Subject’s iliac/femoral access is compatible a 16 French sheath
•7.Subject that has a previously implanted endograft that has migrated or,
•has a Type 1a endoleak (Revision Group) or,
•will undergo implantation of an endograft that in the opinion of the Investigator will be at increased risk of above mentioned complications (Primary Group).

•1.Subject has known allergy to the EndoAnchor implant material (nickel, chromium, molybdenum, or cobalt)
•2.Subject has a life expectancy less than 1 year
•3.Subject is participating in a clinical study or registry that, in the Investigator’s opinion, may conflict or may have a negative impact on the subject’s safety
•4.Subject has already been implanted with an EndoAnchor device in a procedure performed prior to the index procedure
•5.Subject has an active or known history of bleeding diathesis
•6.Subject has a condition that threatens to infect the endograft (active bacteremia, or infections that carry increased risk of endograft infection)
•7.Infrarenal aortic neck with significant thrombus or calcium that precludes adequate EndoAnchor penetration of the aortic wall
•8.Use where, for whatever reason, each EndoAnchor is not anticipated to adequately penetrate into the aortic wall.

发起方

Director Clinical AffairsAptus Endosystems, Inc.