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

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Disease Information

Descriptive Information
Brief Title † ANCHOR (Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry)
Official Title † Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry
Brief Summary Subjects who meet inclusion/exclusion criteria and who are treated with the Aptus Heli-FX EndoAnchor System in conjunction with commercially available non-Aptus Endografts will be divided, as appropriate, into two groups. 1. Primary Group- Subjects undergoing initial (primary) endovascular repair of an AAA where the investigator believes the proximal aortic neck is challenging such that the risk of failure or fixation and/or sealing is great enough so that the use of the Heli-FX EndoAnchor System is warranted. 2. Revision Group- Those subjects who have previously undergone an EVAR procedure where the investigator believes that use of the Heli-FX EndoAnchor System is warranted to A- Treat existing graft migration and/or type 1a endoleak, with or without the concurrent use of other devices. B- Treat subjects believed to be at risk for migration and/or Type 1a endoleak 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.
Detailed Description Study Arms: Abdominal Arm: Subjects with abdominal aortic aneurysms that do not require placement of EndoAnchors™ above the level of the renal arteries will be considered part of the abdominal arm. If a renal artery or any visceral artery requires (a) chimney procedure(s), the subject will be considered part of the Advanced Disease arm. Thoracic Arm: Subjects with thoracic aortic aneurysms that do not require placement of any EndoAnchors proximal to the left common carotid artery (LCCA) or distal to the celiac artery. Thoracic procedures which require arch vessel transposition(s) or bypass procedures to the LCCA or brachiocephalic artery, chimney procedures into any arch or visceral artery(s), or hybrid open-endovascular repairs to the aorta will be considered part of the Advanced Disease Arm. Advanced Disease Arm: To collect data on consecutively treated patients, the Advanced Disease Arm will be comprised of subjects that required placement of EndoAnchors proximal to the LCCA or in the visceral segment of the aorta distal to the celiac artery and proximal to the renal arteries. Subjects with thoracic procedures which require arch vessel transposition(s) or bypass (except to the left subclavian artery) or hybrid open-endovascular procedures as well as those with abdominal or thoracic procedures that require chimney procedures into any renal or visceral artery should also be included in the Advanced Disease arm. Primary Group: Assess the Aptus HeliFX Aortic Securement System placed at the time of initial endograft implantation, either to prevent endograft migration and Type Ia endoleak, or to treat Type Ia endoleak evident at the time of implantation. Revision Group: Assess the Aptus HeliFX™ Aortic Securement System in subjects with previously implanted commercial endografts, for the prevention of graft migration and the treatment of Type Ia endoleak.
Study Phase N/A
Study Type † Observational
Study Design †
Primary Outcome Measure † The Registry has composite Primary Efficacy Endpoints and composite Primary Safety endpoints, tabulated separately for the abdominal, thoracic, and advanced disease arms.
Secondary Outcome Measure † Clinical Success (reflecting the clinical performance and Safety of the Aptus Heli-FX EndoAnchor System) and frequency of aneurysm-related secondary interventions.
Condition † Abdominal Aortic Aneurysm
Intervention † DeviceAptus Heli-FX EndoAnchor System
Study Arms / Comparison Groups Primary Group Initial placement of a commercially available AAA/TAA endograft with the concurrent use of Aptus Heli-FX™ EndoAnchor System (Heli-FX) Revision Group Revision of a previously placed Aptus AAA/TAA endograft with the concurrent use of Aptus Heli-FX™ EndoAnchor System (Heli-FX)
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Device
Estimated Enrollment † 2000
Start Date † April 2012
Completion Date April 2024
Primary Completion Date April 2020
Eligibility Criteria † 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
Gender All
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Karla Betz, karla.h.betz@medtronic.com
Location Countries † France
Administrative Information
NCT ID † NCT01534819
Organization ID Anchor Post Market Registry
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Medtronic Endovascular
Collaborators ††
Investigators † Principal Investigator: Jean-Paul de Vries, MD, St Antonius Hospital - Nieuwegein, Netherlands
Information Provided By
Verification Date January 2017
First Received Date † February 9, 2012
Last Updated Date May 22, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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