ANCHOR (Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry) (ANCHOR)

March 15, 2024 updated by: Medtronic Cardiovascular

Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry

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.

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1090

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Concord, Australia, NSW 2139
        • Concord Repatriation General Hospital
      • Dandenong, Australia, VIC 3175
        • Dandenong Hospital
      • Perth, Australia
        • Sir Charles Gairdner Hospital
      • Perth, Australia, WA 6000
        • Royal Perth Hospital
      • St. Leonards, Australia, NSW 2065
        • Royal North Shore Hospital
      • Innsbruck, Austria
        • A.ö. Landeskrankenhaus - Universitätskliniken Innsbruck
      • Wien, Austria
        • Allgemeines Krankenhaus - Universitätskliniken Wien
      • Rennes, France
        • Hôpital Pontchaillou
      • Strasbourg, France
        • Nouvel Hopital Civil
      • Aachen, Germany
        • Medizinische Fakultät der RWTH
      • Berlin, Germany
        • Deutsches Herzzentrum
      • Heidelberg, Germany
        • University Hospital Heidelberg
      • Leipzig, Germany
        • Park Hospital Leipzig
      • Lingen, Germany
        • St. Bonifatius Hospital
      • Ludwigsburg, Germany
        • Klinikum Ludwigsburg
      • Munich, Germany
        • LMU Kilinikum der Universitaet Muenchen
      • Munich, Germany
        • Technical University of Munich
      • Munster, Germany
        • St. Franzsikus-Hospital GmbH
      • Nuremberg, Germany
        • Klinikum Nuremberg
      • Florence, Italy
        • Azienda Ospedaliero-Universitaria Careggi
      • Roma, Italy
        • AO Universitaria Policlinico
      • Salerno, Italy, 84131
        • Unihospital San Giovanni di Dio Ruggi d'Aragona
      • Siena, Italy
        • University of Siena
      • Torino, Italy
        • Azienda Ospedaliera Ordine Mauriziano di Torino
      • Arnhem, Netherlands
        • Rijnstate Hospital
      • Enschede, Netherlands
        • Medisch Spectrum Twente
      • Nieuwegein, Netherlands
        • St. Antonius Hospital
      • Rotterdam, Netherlands
        • Maasstad Hospital Rotterdam
      • Utrecht, Netherlands
        • UMC Utrecht
      • Auckland, New Zealand
        • Auckland City Hospital
      • Auckland, New Zealand, 1023
        • Auckland City Hospital
      • Nové Mesto, Slovakia
        • Narodny ustav srdcovych a cievnych chorob
      • Barcelona, Spain
        • Thorax Institute Hospital Clinic
      • Donostia / San Sebastián, Spain
        • Hospital Universitario Donostia
      • Valladolid, Spain
        • Hospital Clínico Universitario de Valladolid
      • Malmo, Sweden
        • Malmö University Hospital
      • Lausanne, Switzerland
        • Centre Hospitalier Universitaire Vaudois
      • Zürich, Switzerland
        • Universitatsspital Zurich
      • Liverpool, United Kingdom
        • The Royal Liverpool and NHS Broadgreen University Hospitals - Royal Liverpool University Hospital
      • London, United Kingdom
        • Imperial College Healthcare NHS Trust
      • Manchester, United Kingdom
        • Wythenshawe Hospital
      • Newcastle upon Tyne, United Kingdom
        • The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama
    • Arizona
      • Phoenix, Arizona, United States, 84006
        • Abrazo Arizona Heart Institute
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • John L McClellan Memorial Veterans Hospital
    • California
      • Loma Linda, California, United States, 92357
        • VA Loma Linda Medical Center
      • Mountain View, California, United States, 94040
        • El Camino Hospital
      • Torrance, California, United States, 90509
        • Harbor - UCLA Medical Center
      • Torrance, California, United States, 90502-2004
        • University of California Irvine Medical Center
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School of Medicine
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • MedStar Georgetown University Hospital Vascular Surgery Dept.
    • Florida
      • Miami, Florida, United States, 33176
        • Baptist Cardiac & Vascular Institute
      • Orlando, Florida, United States, 32751
        • Florida Hospital
      • Tampa, Florida, United States, 33606
        • University of South Florida
    • Georgia
      • Atlanta, Georgia, United States, 30322-1059
        • Emory University Hospital
    • Hawaii
      • Honolulu, Hawaii, United States, 96819
        • Kaiser Permanente Moanalua Medical Center and Clinic
    • Illinois
      • Peoria, Illinois, United States, 61614
        • HeartCare Midwest
      • Skokie, Illinois, United States, 60077
        • Evanston Hospital
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
      • Baltimore, Maryland, United States, 21401
        • Johns Hopkins Bayview Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess-Harvard
    • Michigan
      • Flint, Michigan, United States, 98507
        • Michigan Vascular Center
      • Royal Oak, Michigan, United States, 48703
        • William Beaumont Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine, Barnes Jewish West County Hospital
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • New York, New York, United States, 10016
        • New York University Langone Medical Center
      • New York, New York, United States, 10029
        • The Mount Sinai Hospital
      • New York, New York, United States, 11219
        • Maimonides Medical Center
      • Queensbury, New York, United States, 12804
        • Vascular Health Partners
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
    • North Carolina
      • Asheville, North Carolina, United States, 28806
        • Mission Hospital
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina (UNC) Memorial Hospital
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Wormleysburg, Pennsylvania, United States, 17043
        • UPMC Pinnacle Harrisburg Campus
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina (MUSC)
      • West Columbia, South Carolina, United States, 29169
        • Lexington Medical Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • CHI Memorial Hospital Chattanooga
      • Memphis, Tennessee, United States, 38120
        • Baptist Memorial Hospital-Memphis
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Austin, Texas, United States, 78756
        • Cardiothoracic and Vascular Surgeons
      • Temple, Texas, United States, 76508
        • Scott and White Medical Center
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General Hospital
    • Washington
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center, University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Protocol B, abdominal arm, revision group
AAA subjects with previously implanted commercial endografts for the treatment of graft migration and/or Type Ia endoleak
Use of the EndoAnchor™ in conjunction with endograft
Other Names:
  • Heli-FX™
  • Heli-FX™ EndoAnchor™ System
implantation of a device inserted through an artery
Protocol B, abdominal arm, primary group
AAA subjects 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.
Use of the EndoAnchor™ in conjunction with endograft
Other Names:
  • Heli-FX™
  • Heli-FX™ EndoAnchor™ System
implantation of a device inserted through an artery
Protocol B, thoracic arm, revision group
TAA subjects with previously implanted commercial endografts for the treatment of migration and/or Type Ia and/or Type Ib endoleak at the proximal or distal attachment site
Use of the EndoAnchor™ in conjunction with endograft
Other Names:
  • Heli-FX™
  • Heli-FX™ EndoAnchor™ System
implantation of a device inserted through an artery
Protocol B, thoracic arm, primary group
TAA subjects at the time of initial endograft implantation either to prevent endograft migration and Type I endoleak, or to treat Type Ia and/or Ib endoleak at the proximal or distal attachment site evident at the time of implantation
Use of the EndoAnchor™ in conjunction with endograft
Other Names:
  • Heli-FX™
  • Heli-FX™ EndoAnchor™ System
implantation of a device inserted through an artery
Protocol B, advanced disease arm, revision group
Advanced disease subjects with previously implanted commercial endografts for the treatment of migration and/or Type Ia and/or Type Ib endoleak at the proximal or distal attachment site
Use of the EndoAnchor™ in conjunction with endograft
Other Names:
  • Heli-FX™
  • Heli-FX™ EndoAnchor™ System
implantation of a device inserted through an artery
Protocol B, advanced disease arm, primary group
Advanced disease subjects at the time of initial endograft implantation either to prevent endograft migration and Type I endoleak, or to treat Type Ia and/or Ib endoleak at the proximal or distal attachment site evident at the time of implantation.
Use of the EndoAnchor™ in conjunction with endograft
Other Names:
  • Heli-FX™
  • Heli-FX™ EndoAnchor™ System
implantation of a device inserted through an artery
Protocol C, abdominal arm, short neck, primary group
Planned use of Heli-FX™ in conjunction with the Endurant II/IIs endograft in AAA subjects with short proximal necks (≥ 4 mm and < 10 mm) in primary group.
Use of the EndoAnchor™ in conjunction with endograft
Other Names:
  • Heli-FX™
  • Heli-FX™ EndoAnchor™ System
implantation of a device inserted through an artery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Protocol B has composite primary safety endpoints, tabulated separately for the abdominal, thoracic and advanced disease arms
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

Through 12 months
Protocol B has composite primary effectiveness endpoints, tabulated separately for the abdominal, thoracic and advanced disease arms
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

Through 12 months
Protocol C has composite primary safety endpoint
Time Frame: Through 12 months

The primary safety endpoint is defined by:

  1. device-related serious adverse events at 12 months
  2. 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

Through 12 months
Protocol C have composite primary effectiveness endpoint
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:

  1. migration at 12 months and
  2. Type I endoleak at the targeted attachment site(s) at 12 months
Through 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Through 5 years
  1. Technical success defined as successful deployment of EndoAnchor™ at their intended location. Technical success will be assessed separately for the target attachment sites; proximally and/or distally
  2. Clinical success will be defined as the successful implantation of the suggested number of EndoAnchor™ at the index procedure, and the absence of: death as a result of aneurysm-related treatment; Type Ia endoleak; Type Ib endoleak (TAA and advanced disease only); endograft infection; endograft migration; loss of endograft fabric integrity as a result of the EndoAnchor™; Rupture of the treated aneurysm; Conversion to open surgical repair
  3. Secondary aneurysm-related interventions after EndoAnchor™ implantation
  4. all-cause mortality
  5. Freedom from EndoAnchor™ fracture
Through 5 years
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.
Time Frame: Through 5 years
  1. Technical success defined as successful deployment of EndoAnchor™ at their intended location. Technical success will be assessed separately for the target attachment sites; proximally and/or distally
  2. Clinical success will be defined as the successful implantation of EndoAnchor™ at the index procedure, and the absence of: aneurysm-related mortality; Type Ia endoleak; endograft infection; endograft migration; loss of endograft fabric integrity as a result of the EndoAnchor™; Rupture of the treated aneurysm; Conversion to open surgical repair
  3. Secondary aneurysm-related interventions after EndoAnchor™ implantation
  4. all-cause mortality
  5. EndoAnchor™ implant fracture
Through 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jean-Paul de Vries, MD, Universitair Medisch Centrum Groningen, Netherlands
  • Principal Investigator: William Jordan, MD, Augusta University Health, United States

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2012

Primary Completion (Actual)

December 3, 2020

Study Completion (Estimated)

December 3, 2025

Study Registration Dates

First Submitted

February 9, 2012

First Submitted That Met QC Criteria

February 14, 2012

First Posted (Estimated)

February 17, 2012

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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