ANCHOR (Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry)

Completed

Conditions studied: Aortic Aneurysm

In brief

The ANCHOR registry is a multi-center, post-market, non-interventional, non-randomized, prospective study. Subjects must sign an ICF prior to obtaining any study specific information. Subjects are eligible to be consented up to 30 days post-procedure. Enrolled subjects will be followed as per local 'standard of care' for up to 5 years post procedure. Study recommended follow-up is per SVS and ESVS guidance.

Key facts

Study ID

NCT01534819

Run by

Medtronic Cardiovascular

People needed

1090

Starts

2012-04-01

Expected to finish

2026-04-08

Last updated by the study team

2026-04-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with asymptomatic, symptomatic, or ruptured 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 followup evaluations
• Subject has a previously implanted endograft or will be undergoing repair, 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 Heli-FX™ in the IFU
• Subject's iliac/femoral access is compatible with:
• a 16 French sheath (abdominal subjects)
• 18 French sheath (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 I endoleak within the aorta or will undergo implantation of an endograft that in the opinion of the investigator will be at increased risk of such complications

You may not qualify if…

• Subject has known allergy to the EndoAnchor™ implant material (nickel, chromium, molybdenum, or cobalt)
• Subject has a life expectancy of 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 EndoAnchor™ 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 involves an area to be treated with EndoAnchor™
• Subject has Marfan Syndrome, Ehlers Danlos Syndrome, or another collagen vascular disease
• Subject is pregnant
• Protocol C:
• Inclusion criteria:
• Subjects with asymptomatic or symptomatic abdominal aortic aneurysms that will receive the Heli-FX™ in conjunction with the Endurant II/IIs endograft as part of their planned EVAR treatment
• 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 followup evaluations
• Subject will be undergoing AAA repair with the bifurcated main body Endurant II/IIs stent graft in conjunction with Heli-FX™ with a proximal neck length of ≥ 4mm to < 10mm and treated in accordance with the Endurant II/IIs and Heli-FX™ IFUs
• Subject's iliac/femoral access is compatible with a 16 French sheath
• Exclusion criteria:
• Subject has known allergy to the EndoAnchor™ implant material (nickel, chromium, molybdenum, or cobalt)
• Subject has a life expectancy of 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 previously treated with EndoAnchor™ implants in the same segment of the aorta that will be treated within the registry, or has a previously implanted AAA endograft that has migrated or has a Type Ia endoleak, or is being treated for a ruptured abdominal aortic aneurysm, or has planned usage of an Endurant II/IIs AUI main body stent graft configuration
• Subject has an active or known history of bleeding diathesis

Where it is running

• Abrazo Arizona Heart Institute — Phoenix, Arizona, United States
• John L McClellan Memorial Veterans Hospital — Little Rock, Arkansas, United States
• VA Loma Linda Medical Center — Loma Linda, California, United States
• El Camino Hospital — Mountain View, California, United States
• University of California Irvine Medical Center — Torrance, California, United States
• Harbor - UCLA Medical Center — Torrance, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• MedStar Georgetown University Hospital Vascular Surgery Dept. — Washington D.C., District of Columbia, United States
• Baptist Cardiac & Vascular Institute — Miami, Florida, United States
• Florida Hospital — Orlando, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Kaiser Permanente Moanalua Medical Center and Clinic — Honolulu, Hawaii, United States
• HeartCare Midwest — Peoria, Illinois, United States
• Evanston Hospital — Skokie, Illinois, United States
• Southern Illinois University — Springfield, Illinois, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
• Beth Israel Deaconess-Harvard — Boston, Massachusetts, United States
• Michigan Vascular Center — Flint, Michigan, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• Washington University School of Medicine, Barnes Jewish West County Hospital — St Louis, Missouri, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Albany Medical Center — Albany, New York, United States
• University of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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