ANCHOR (Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry) (NCT01534819) | Clinical Trial Compass
CompletedNot Applicable
ANCHOR (Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry)
United States1,090 participantsStarted 2012-04
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
âś“. Subjects with asymptomatic, symptomatic, or ruptured aortic aneurysms
✓. Subject ≥ 18 years old
âś“. Subject has provided written informed consent, either before or less than or equal to 30 calendar days after the index procedure
âś“. Subject is willing and able to comply with standard of care followup evaluations
âś“. Subject has a previously implanted endograft or will be undergoing repair, with one of the following aortic aneurysm endograft devices:
âś“. Subject's iliac/femoral access is compatible with:
âś“. 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
Exclusion criteria
✕. Subject has known allergy to the EndoAnchor™ implant material (nickel, chromium, molybdenum, or cobalt)
âś•. Subject has a life expectancy of less than 1 year
âś•. 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
What they're measuring
1
Protocol B has composite primary safety endpoints, tabulated separately for the abdominal, thoracic and advanced disease arms
Timeframe: Through 12 months
2
Protocol B has composite primary effectiveness endpoints, tabulated separately for the abdominal, thoracic and advanced disease arms
Timeframe: Through 12 months
3
Protocol C has composite primary safety endpoint
Timeframe: Through 12 months
4
Protocol C have composite primary effectiveness endpoint
. Subject has an active or known history of bleeding diathesis
âś•. 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