Last updated on February 2018

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Abdominal aortic aneurysm
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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 calendar 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 aortic aneurysm endograft devices:
  • Cook Zenith or Cook Zenith TX2
  • Gore Excluder or TAG
  • Medtronic AneuRx
  • Medtronic Talent
  • Medtronic Endurant or Valiant
  • Any additional third party AAA endograft device that is commercially available and listed as compatible with the Aptus Heli-FX EndoAnchor System in the Instructions for Use
  • Subject's iliac/femoral access is compatible
  • a 16 French sheath (abdominal subjects)
  • 18 French seath (thoracic subjects)
  • Selected 16 or 18 French sheath, as applicable to the device selected for use (advanced disease subjects)
  • Subject has a previously implanted endograft that has migrated or has a Type Ia endoleak within the aorta (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 EndoAnchor 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 was treated with EndoAnchors in the same segment of the aorta that will be treated in the registry
  • 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)
  • Significant thrombus or calcium at the location of planned EndoAnchor implantation that precludes adequate EndoAnchor penetration of the aortic wall
  • Use where, for whatever reason, each EndoAnchor is not anticipated to adequately penetrate into the aortic wall
  • Subject has an aortic dissection that invloves an area to be treated with EndoAnchors
  • Subject has Marfan Syndrome, Ehlers Danlos Syndrome, or another collagen vascular disease
  • Subject is pregnant

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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