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 States, Australia, Austria1,090 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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. Subject's iliac/femoral access is compatible with:
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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 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