EndoAnchor™
DeviceUse of the EndoAnchor™ in conjunction with endograft
Other names: Heli-FX™, Heli-FX™ EndoAnchor™ System
NCT Number: NCT01534819
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.
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Notify Me18 year and older
All sexes
Observational
Concord Repatriation General Hospital, Concord, Australia
The objective of the ANCHOR registry is to expand the clinical knowledge based on the use of the Heli-FX™ EndoAnchor™ System. This registry will include "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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Protocol B:
Inclusion criteria
Exclusion criteria
Protocol C:
Inclusion criteria
Exclusion criteria
Use of the EndoAnchor™ in conjunction with endograft
Other names: Heli-FX™, Heli-FX™ EndoAnchor™ System
implantation of a device inserted through an artery
Time frame: Through 12 months
The primary safety endpoint is defined by:
i. freedom from device-related serious adverse events at 12 months and ii. freedom from procedure-related serious adverse events at 12 months iii. freedom from aneurysm-related mortality defined as: i. death within 30 days of the index procedure ii. death within 30 days of a secondary procedure to address the aneurysm iii. death from rupture of the treated aneurysm
Time frame: Through 12 months
The primary effectiveness endpoint requires all of the following:
i successful implantation of the minimum number of EndoAnchor™ and ii freedom from migration at 12 months and iii freedom from Type I endoleak at the targeted attachment site(s) at 12 months
Time frame: Through 12 months
The primary safety endpoint is defined by:
i. death within 30 days of the index procedure ii. death within 30 days of a secondary procedure to address the aneurysm iii. death from rupture of the treated aneurysm
Time frame: Through 12 months
The primary effectiveness endpoint is treatment success which is defined as the successful implantation of EndoAnchor™ implants at the index procedure, and the absence of:
Time frame: Through 5 years
Time frame: Through 5 years
Medtronic Cardiovascular
Industry
Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry
Acronym: ANCHOR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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