Clinical trial NCT01534819: ANCHOR (Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry)
Official title: Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Aortic Aneurysm
Keywords: Endograft
Endurant
Heli-FX™
EndoAnchor™
Short neck
Endovascular treatment
Interventional treatment of aortic aneurysm
Abdominal aortic aneurysm
AAA
Thoracic aortic aneurysm
TAA
Advanced disease
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2012-02-17
Enrollment: 1090
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Protocol B: subjects with AAA, TAA, or advanced aortic aneurysmal disease treated with the Heli-FX™ EndoAnchor™ System in conjunction with commercially available abdominal and thoracic Endografts, in both "Primary" and "Revision" settings and who meet the inclusion/exclusion criteria.

Protocol C:The intended population will include those subjects with short (≥ 4 mm and \< 10 mm) infrarenal proximal neck lengths who are appropriate candidates for infrarenal AAA treatment with the Heli-FX™ EndoAnchor™ System in conjunction with the Endurant II/IIs endograft system and who meet the inclusion/exclusion criteria

Brief 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.

Detailed description: 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.

Eligibility criteria: Protocol B:

Inclusion criteria:

1. Subjects with asymptomatic, symptomatic, or ruptured aortic aneurysms
2. Subject ≥ 18 years old
3. Subject has provided written informed consent, either before or less than or equal to 30 calendar days after the index procedure
4. Subject is willing and able to comply with standard of care followup evaluations
5. 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
6. 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)
7. 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:

1. Subject has known allergy to the EndoAnchor™ implant material (nickel, chromium, molybdenum, or cobalt)
2. Subject has a life expectancy of less than 1 year
3. 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
4. Subject was treated with EndoAnchor™ in the same segment of the aorta that will be treated in the registry
5. Subject has an active or known history of bleeding diathesis
6. Subject has a condition that threatens to infect the endograft (active bacteremia, or infections that carry increased risk of endograft infection)
7. Significant thrombus or calcium at the location of planned EndoAnchor™ implantation that precludes adequate EndoAnchor™ penetration of the aortic wall
8. Use where, for whatever reason, each EndoAnchor™ is not anticipated to adequately penetrate into the aortic wall
9. Subject has an aortic dissection that involves an area to be treated with EndoAnchor™
10. Subject has Marfan Syndrome, Ehlers Danlos Syndrome, or another collagen vascular disease
11. 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
* 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™ device implantation that precludes adequate EndoAnchor™ implant penetration of the aortic wall
* Use where, for whatever reason, each EndoAnchor™ implant is not anticipated to adequately penetrate into the aortic wall
* Subject has an aortic dissection that involves an area to be treated with EndoAnchor™ implants
* Subject has Marfan Syndrome, Ehlers Danlos Syndrome, or another collagen vascular disease
* Subject is pregnant
* Physician does not intend to treat subject on-label per the Endurant II/IIs and Heli-FX™ IFU requirements or if the physician intends to use Heli-FX™ in a chimney procedure.

Primary outcomes:
measure: Protocol B has composite primary safety endpoints, tabulated separately for the abdominal, thoracic and advanced disease arms
timeFrame: Through 12 months
measure: Protocol B has composite primary effectiveness endpoints, tabulated separately for the abdominal, thoracic and advanced disease arms
timeFrame: Through 12 months
measure: Protocol C has composite primary safety endpoint
timeFrame: Through 12 months
measure: Protocol C have composite primary effectiveness endpoint
timeFrame: Through 12 months
Secondary outcomes:
measure: Protocol B has the secondary endpoints chosen to reflect the clinical success and safety of Heli-FX™. Each of the secondary endpoints will be measured individually at 30 days and 12 months and yearly thereafter.
timeFrame: Through 5 years
measure: Protocol C has the secondary endpoints chosen to reflect the clinical success and safety of Heli-FX™. Each of the secondary endpoints will be measured individually at 30 days and 12 months and yearly thereafter.
timeFrame: Through 5 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Phoenix
country: United States
facility: Abrazo Arizona Heart Institute
state: Arizona
city: Little Rock
country: United States
facility: John L McClellan Memorial Veterans Hospital
state: Arkansas
city: Loma Linda
country: United States
facility: VA Loma Linda Medical Center
state: California
city: Mountain View
country: United States
facility: El Camino Hospital
state: California
city: Torrance
country: United States
facility: University of California Irvine Medical Center
state: California
city: Torrance
country: United States
facility: Harbor - UCLA Medical Center
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Washington
country: United States
facility: MedStar Georgetown University Hospital Vascular Surgery Dept.
state: District of Columbia
city: Miami
country: United States
facility: Baptist Cardiac & Vascular Institute
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Honolulu
country: United States
facility: Kaiser Permanente Moanalua Medical Center and Clinic
state: Hawaii
city: Peoria
country: United States
facility: HeartCare Midwest
state: Illinois
city: Skokie
country: United States
facility: Evanston Hospital
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess-Harvard
state: Massachusetts
city: Flint
country: United States
facility: Michigan Vascular Center
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine, Barnes Jewish West County Hospital
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
city: New York
country: United States
facility: The Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Maimonides Medical Center
state: New York
city: Queensbury
country: United States
facility: Vascular Health Partners
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Asheville
country: United States
facility: Mission Hospital
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina (UNC) Memorial Hospital
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Wormleysburg
country: United States
facility: UPMC Pinnacle Harrisburg Campus
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: West Columbia
country: United States
facility: Lexington Medical Center
state: South Carolina
city: Chattanooga
country: United States
facility: CHI Memorial Hospital Chattanooga
state: Tennessee
city: Memphis
country: United States
facility: Baptist Memorial Hospital-Memphis
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Cardiothoracic and Vascular Surgeons
state: Texas
city: Temple
country: United States
facility: Scott and White Medical Center
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Seattle
country: United States
facility: Harborview Medical Center, University of Washington
state: Washington
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
city: Dandenong
country: Australia
facility: Dandenong Hospital
city: Perth
country: Australia
facility: Royal Perth Hospital
city: Perth
country: Australia
facility: Sir Charles Gairdner Hospital
city: St. Leonards
country: Australia
facility: Royal North Shore Hospital
city: Innsbruck
country: Austria
facility: A.ö. Landeskrankenhaus - Universitätskliniken Innsbruck
city: Wien
country: Austria
facility: Allgemeines Krankenhaus - Universitätskliniken Wien
city: Rennes
country: France
facility: Hôpital Pontchaillou
city: Strasbourg
country: France
facility: Nouvel Hôpital Civil
city: Aachen
country: Germany
facility: Medizinische Fakultät der RWTH
city: Berlin
country: Germany
facility: Deutsches Herzzentrum
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
city: Leipzig
country: Germany
facility: Park Hospital Leipzig
city: Lingen
country: Germany
facility: St. Bonifatius Hospital
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg
city: Munich
country: Germany
facility: LMU Kilinikum der Universitaet Muenchen
city: Munich
country: Germany
facility: Technical University of Munich
city: Munster
country: Germany
facility: St. Franzsikus-Hospital GmbH
city: Nuremberg
country: Germany
facility: Klinikum Nuremberg
city: Florence
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
city: Roma
country: Italy
facility: AO Universitaria Policlinico
city: Salerno
country: Italy
facility: Unihospital San Giovanni di Dio Ruggi d'Aragona
city: Siena
country: Italy
facility: University of Siena
city: Torino
country: Italy
facility: Azienda Ospedaliera Ordine Mauriziano di Torino
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
city: Rotterdam
country: Netherlands
facility: Maasstad Hospital Rotterdam
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Nové Mesto
country: Slovakia
facility: Narodny ustav srdcovych a cievnych chorob
city: Barcelona
country: Spain
facility: Thorax Institute Hospital Clinic
city: Donostia / San Sebastián
country: Spain
facility: Hospital Universitario Donostia
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Malmo
country: Sweden
facility: Malmo University Hospital
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Zürich
country: Switzerland
facility: UniversitätsSpital Zürich
city: Liverpool
country: United Kingdom
facility: The Royal Liverpool and NHS Broadgreen University Hospitals - Royal Liverpool University Hospital
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Study officials:
affiliation: Universitair Medisch Centrum Groningen, Netherlands
name: Jean-Paul de Vries, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Augusta University Health, United States
name: William Jordan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jordan WD Jr, Mehta M, Varnagy D, Moore WM Jr, Arko FR, Joye J, Ouriel K, de Vries JP; Aneurysm Treatment using the Heli-FX Aortic Securement System Global Registry (ANCHOR) Workgroup Members. Results of the ANCHOR prospective, multicenter registry of EndoAnchors for type Ia endoleaks and endograft migration in patients with challenging anatomy. J Vasc Surg. 2014 Oct;60(4):885-92.e2. doi: 10.1016/j.jvs.2014.04.063. Epub 2014 Jul 31.
citation: Jordan WD Jr, Mehta M, Ouriel K, Arko FR, Varnagy D, Joye J, Moore WM Jr, de Vries JP. One-year results of the ANCHOR trial of EndoAnchors for the prevention and treatment of aortic neck complications after endovascular aneurysm repair. Vascular. 2016 Apr;24(2):177-86. doi: 10.1177/1708538115590727. Epub 2015 Jun 10.
citation: van Noort K, Vermeulen JJM, Goudeketting SR, Ouriel K, Jordan WD Jr, Panneton JM, Slump CH, de Vries JPM. Sustainability of Individual EndoAnchor Implants in Therapeutic Use to Treat Type Ia Endoleak After Endovascular Aneurysm Repair. J Endovasc Ther. 2019 Jun;26(3):369-377. doi: 10.1177/1526602819837753. Epub 2019 Mar 25.
citation: Arko FR 3rd, Stanley GA, Pearce BJ, Henretta JP, Fugate MW, Mehta M, Torsello G, Panneton JM, Garrett HE Jr. Endosuture aneurysm repair in patients treated with Endurant II/IIs in conjunction with Heli-FX EndoAnchor implants for short-neck abdominal aortic aneurysm. J Vasc Surg. 2019 Sep;70(3):732-740. doi: 10.1016/j.jvs.2018.11.033. Epub 2019 Mar 6.
citation: Muhs BE, Jordan W, Ouriel K, Rajaee S, de Vries JP. Matched cohort comparison of endovascular abdominal aortic aneurysm repair with and without EndoAnchors. J Vasc Surg. 2018 Jun;67(6):1699-1707. doi: 10.1016/j.jvs.2017.10.059. Epub 2017 Dec 18.
citation: Jordan WD Jr, de Vries JP, Ouriel K, Mehta M, Varnagy D, Moore WM Jr, Arko FR, Joye J, Henretta J. Midterm outcome of EndoAnchors for the prevention of endoleak and stent-graft migration in patients with challenging proximal aortic neck anatomy. J Endovasc Ther. 2015 Apr;22(2):163-70. doi: 10.1177/1526602815574685.
citation: Jordan WD Jr, Ouriel K, Mehta M, Varnagy D, Moore WM Jr, Arko FR, Joye J, de Vries JP; Aneurysm Treatment using the Heli-FX Aortic Securement System Global Registry ANCHOR; Aneurysm Treatment using the Heli-FX Aortic Securement System Global Registry ANCHOR. Outcome-based anatomic criteria for defining the hostile aortic neck. J Vasc Surg. 2015 Jun;61(6):1383-90.e1. doi: 10.1016/j.jvs.2014.12.063. Epub 2015 Feb 28.
citation: de Vries JP, Ouriel K, Mehta M, Varnagy D, Moore WM Jr, Arko FR, Joye J, Jordan WD Jr; Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry ANCHOR Trial. Analysis of EndoAnchors for endovascular aneurysm repair by indications for use. J Vasc Surg. 2014 Dec;60(6):1460-7.e1. doi: 10.1016/j.jvs.2014.08.089. Epub 2014 Oct 3.