ANCHOR (Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry) (ANCHOR)

Trial Purpose and Description

The purpose of the ANCHOR Registry is to expand the clinical knowledge base on the use of the HeliFX Aortic Securement System by including real world use over a broad spectrum of geographies, by a wide variety of practicing clinicians, and with a minimal degree of subject selection criteria.

Ages: 18 years and older

Gender: Both


Eligibility Criteria

Inclusion Criteria:

  • Subjects with asymptomatic, symptomatic, or ruptured abdominal aortic aneurysms
  • Subject ≥ 18 years old
  • Subject has provided written informed consent, either before or less than or equal to 30 days after the index procedure
  • Subject is willing and able to comply with standard of care follow-up evaluations
  • 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 Heli-FX EndoAnchor System in the Instructions for Use
  • Subject's iliac/femoral access is compatible a 16 French sheath
  • Subject has a previously implanted endograft that has migrated or has a Type Ia endoleak (Revision Group) or will undergo implantation of an endograft that in the opinion of the Investigator will be at increased risk of such complications (Primary Group)

Exclusion Criteria:

  • Subject has known allergy to the Heli-FX implant material (nickel, chromium, molybdenum, or cobalt)
  • Subject has a life expectancy less than 1 year
  • 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
  • Subject has already been implanted with a Heli-FX device in a procedure performed prior to the index procedure
  • Subject has an active or known history of bleeding diathesis
  • Subject has a condition that threatens to infect the endograft (active bacteremia, or infections that carry increased risk of endograft infection)
  • Infrarenal aortic neck with significant thrombus or calcium that precludes adequate Heli-FX penetration of the aortic wall
  • Use where, for whatever reason, each Heli-FX is not anticipated to adequately penetrate into the aortic wall.

Aptus Endosystems, Inc.

Dates: 10/29/2012 - 03/31/2016

Last Updated: 12/04/2016

Study HIC#: 1209010766REG

Get Involved

For more information about this study, contact:
Patricia Fugal
+1 203-785-4855
patricia.fugal@yale.edu

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 1-877-978-8348.

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