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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01534819
Recruitment Status : Recruiting
First Posted : February 17, 2012
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

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.


Condition or disease Intervention/treatment
Aortic Aneurysm Device: EndoAnchor™ Procedure: endovascular treament

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.

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry
Actual Study Start Date : April 2012
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2028

Resource links provided by the National Library of Medicine


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
Device: EndoAnchor™
Use of the EndoAnchor™ in conjunction with endograft
Other Names:
  • Heli-FX™
  • Heli-FX™ EndoAnchor™ System

Procedure: endovascular treament
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.
Device: EndoAnchor™
Use of the EndoAnchor™ in conjunction with endograft
Other Names:
  • Heli-FX™
  • Heli-FX™ EndoAnchor™ System

Procedure: endovascular treament
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
Device: EndoAnchor™
Use of the EndoAnchor™ in conjunction with endograft
Other Names:
  • Heli-FX™
  • Heli-FX™ EndoAnchor™ System

Procedure: endovascular treament
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
Device: EndoAnchor™
Use of the EndoAnchor™ in conjunction with endograft
Other Names:
  • Heli-FX™
  • Heli-FX™ EndoAnchor™ System

Procedure: endovascular treament
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
Device: EndoAnchor™
Use of the EndoAnchor™ in conjunction with endograft
Other Names:
  • Heli-FX™
  • Heli-FX™ EndoAnchor™ System

Procedure: endovascular treament
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.
Device: EndoAnchor™
Use of the EndoAnchor™ in conjunction with endograft
Other Names:
  • Heli-FX™
  • Heli-FX™ EndoAnchor™ System

Procedure: endovascular treament
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.
Device: EndoAnchor™
Use of the EndoAnchor™ in conjunction with endograft
Other Names:
  • Heli-FX™
  • Heli-FX™ EndoAnchor™ System

Procedure: endovascular treament
implantation of a device inserted through an artery




Primary Outcome Measures :
  1. 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


  2. 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


  3. 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


  4. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01534819


Contacts
Layout table for location contacts
Contact: Michelle Endo michelle.m.endo@medtronic.com
Contact: Rakel Alexandersdottir rakel.alexandersdottir@medtronic.com

  Hide Study Locations
Locations
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United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35294
Principal Investigator: Benjamin Pearce, MD         
United States, Arizona
Abrazo Arizona Heart Institute Completed
Phoenix, Arizona, United States, 84006
United States, Arkansas
John L McClellan Memorial Veterans Hospital Active, not recruiting
Little Rock, Arkansas, United States, 72205
United States, California
VA Loma Linda Medical Center Active, not recruiting
Loma Linda, California, United States, 92357
El Camino Hospital Active, not recruiting
Mountain View, California, United States, 94040
University of California Irvine Medical Center Recruiting
Torrance, California, United States, 90502-2004
Principal Investigator: Carlos Donayre         
Harbor - UCLA Medical Center Active, not recruiting
Torrance, California, United States, 90509
United States, Connecticut
University of Connecticut John Dempsey Hospital Withdrawn
Farmington, Connecticut, United States, 06030
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06510
Principal Investigator: Naiem Nassiri, MD         
United States, District of Columbia
MedStar Georgetown University Hospital Vascular Surgery Dept. Completed
Washington, District of Columbia, United States, 20007
United States, Florida
Baptist Cardiac & Vascular Institute Active, not recruiting
Miami, Florida, United States, 33176
Florida Hospital Active, not recruiting
Orlando, Florida, United States, 32751
University of South Florida Recruiting
Tampa, Florida, United States, 33606
Principal Investigator: Murray Shames, MD         
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322-1059
Principal Investigator: William Jordan, MD         
United States, Hawaii
Kaiser Permanente Moanalua Medical Center and Clinic Terminated
Honolulu, Hawaii, United States, 96819
United States, Illinois
HeartCare Midwest Completed
Peoria, Illinois, United States, 61614
Evanston Hospital Active, not recruiting
Skokie, Illinois, United States, 60077
Southern Illinois University Terminated
Springfield, Illinois, United States, 62702
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Principal Investigator: Shahab Toursavadkohi         
Johns Hopkins Bayview Medical Center Active, not recruiting
Baltimore, Maryland, United States, 21401
United States, Massachusetts
Beth Israel Deaconess-Harvard Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Marc Schermerhorn, MD         
United States, Michigan
Michigan Vascular Center Recruiting
Flint, Michigan, United States, 98507
Principal Investigator: Nitin Malhotra, MD         
University of Michigan Health System - University Hospital Withdrawn
Michigan Center, Michigan, United States, 48109
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48703
Principal Investigator: Paul Bove, MD         
United States, Missouri
Washington University School of Medicine, Barnes Jewish West County Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Principal Investigator: Jeffery Jim, MD, MS         
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Active, not recruiting
Lebanon, New Hampshire, United States, 03756
United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Principal Investigator: Jeffrey Hnath, MD         
Montefiore Medical Center Active, not recruiting
Bronx, New York, United States, 10467
New York University Langone Medical Center Completed
New York, New York, United States, 10016
The Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Principal Investigator: Vouyouka Ageliki, MD         
Maimonides Medical Center Recruiting
New York, New York, United States, 11219
Principal Investigator: Robert Rhee         
Vascular Health Partners Active, not recruiting
Queensbury, New York, United States, 12804
Stony Brook University Medical Center Recruiting
Stony Brook, New York, United States, 11794
Principal Investigator: Apostolos Tassiopoulos, MD         
United States, North Carolina
Mission Hospital Recruiting
Asheville, North Carolina, United States, 28806
Principal Investigator: John Henretta, MD         
University of North Carolina (UNC) Memorial Hospital Active, not recruiting
Chapel Hill, North Carolina, United States, 27599
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Principal Investigator: Frank Arko, MD         
Duke University Medical Center Active, not recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic Active, not recruiting
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
UPMC Pinnacle Harrisburg Campus Recruiting
Wormleysburg, Pennsylvania, United States, 17043
Principal Investigator: David Loran, MD         
United States, South Carolina
Medical University of South Carolina (MUSC) Recruiting
Charleston, South Carolina, United States, 29425
Principal Investigator: Ravi Veeraswamy         
Lexington Medical Center Recruiting
West Columbia, South Carolina, United States, 29169
Principal Investigator: William M Moore, MD         
United States, Tennessee
CHI Memorial Hospital Chattanooga Recruiting
Chattanooga, Tennessee, United States, 37403
Principal Investigator: Mark W Fugate, MD         
Baptist Memorial Hospital-Memphis Recruiting
Memphis, Tennessee, United States, 38120
Principal Investigator: H. Edward Garrett, MD         
TriStar Centennial Medical Center Withdrawn
Nashville, Tennessee, United States, 37203
Vanderbilt University Medical Center Active, not recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Cardiothoracic and Vascular Surgeons Recruiting
Austin, Texas, United States, 78756
Principal Investigator: Mazin Foteh         
Scott and White Medical Center Recruiting
Temple, Texas, United States, 76508
Principal Investigator: William Bohannon, MD         
United States, Virginia
Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
Principal Investigator: Jean Panneton, MD         
United States, Washington
Harborview Medical Center, University of Washington Completed
Seattle, Washington, United States, 98104
Australia
Concord Repatriation General Hospital Recruiting
Concord, Australia, NSW 2139
Principal Investigator: Anthony Freeman         
Dandenong Hospital Recruiting
Dandenong, Australia, VIC 3175
Principal Investigator: Yen-Ming Kuan         
Royal Perth Hospital Not yet recruiting
Perth, Australia, WA 6000
Principal Investigator: Patrice Mwipatayi         
Sir Charles Gairdner Hospital Recruiting
Perth, Australia
Principal Investigator: Shirley Jansen         
Royal North Shore Hospital Recruiting
St. Leonards, Australia, NSW 2065
Principal Investigator: Vikram Puttaswamy         
Austria
A.ö. Landeskrankenhaus - Universitätskliniken Innsbruck Recruiting
Innsbruck, Austria
Principal Investigator: Martin Freund, MD         
Allgemeines Krankenhaus - Universitätskliniken Wien Active, not recruiting
Wien, Austria
France
Henri Mondor Hospital Withdrawn
Creteil, France
Hôpital Pontchaillou Recruiting
Rennes, France
Principal Investigator: Alain Cardon, MD         
Nouvel Hôpital Civil Recruiting
Strasbourg, France
Principal Investigator: Fabien Thaveau, MD         
Germany
Medizinische Fakultät der RWTH Active, not recruiting
Aachen, Germany
Deutsches Herzzentrum Active, not recruiting
Berlin, Germany
Cardiovascular Center Frankfurt Withdrawn
Frankfurt, Germany
University Hospital Heidelberg Recruiting
Heidelberg, Germany
Principal Investigator: Dittmar Bockler, MD         
Park Hospital Leipzig Recruiting
Leipzig, Germany
Principal Investigator: Dierk Scheinert, MD         
Principal Investigator: Andrej Schmidt, MD         
St. Bonifatius Hospital Active, not recruiting
Lingen, Germany
Klinikum Ludwigsburg Terminated
Ludwigsburg, Germany
LMU Kilinikum der Universitaet Muenchen Terminated
Munich, Germany
Technical University of Munich Terminated
Munich, Germany
St. Franzsikus-Hospital GmbH Recruiting
Munster, Germany
Principal Investigator: Giovanni Torsello, MD         
Klinikum Nuremberg Completed
Nuremberg, Germany
Pius Hospital Active, not recruiting
Oldenburg, Germany
Katharinen hospital Active, not recruiting
Stuttgart, Germany
Italy
Azienda Ospedaliero-Universitaria Careggi Recruiting
Florence, Italy
Principal Investigator: Carlo Pratesi, MD         
AO Universitaria Policlinico Recruiting
Roma, Italy
Principal Investigator: Pierfancesco Veroux, MD         
Unihospital San Giovanni di Dio Ruggi d'Aragona Recruiting
Salerno, Italy, 84131
Principal Investigator: Giancarlo Accarino         
University of Siena Terminated
Siena, Italy
Azienda Ospedaliera Ordine Mauriziano di Torino Recruiting
Torino, Italy
Principal Investigator: Michelangelo Ferri, MD         
Netherlands
Rijnstate Hospital Recruiting
Arnhem, Netherlands
Principal Investigator: Michael Reijnen, MD         
Medisch Spectrum Twente Active, not recruiting
Enschede, Netherlands
Universitair Medisch Centrum Groningen Not yet recruiting
Groningen, Netherlands
Contact: Jean-Paul De Vries, MD         
St. Antonius Hospital Active, not recruiting
Nieuwegein, Netherlands
Maasstad Hospital Rotterdam Active, not recruiting
Rotterdam, Netherlands
UMC Utrecht Completed
Utrecht, Netherlands
New Zealand
Auckland City Hospital Recruiting
Auckland, New Zealand, 1023
Principal Investigator: Venu Bhamidipaty         
Poland
Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM Withdrawn
Szczecin, Poland
Slovakia
Narodny ustav srdcovych a cievnych chorob Recruiting
Nové Mesto, Slovakia
Principal Investigator: Petr Varejka         
Spain
Thorax Institute Hospital Clinic Recruiting
Barcelona, Spain
Principal Investigator: Vincent Riambau, MD         
Hospital Universitario Donostia Recruiting
Donostia / San Sebastián, Spain
Principal Investigator: Mariano de Blas, MD         
Hospital Clínico Universitario de Valladolid Recruiting
Valladolid, Spain
Principal Investigator: Carlos Vaquero Puerta, MD         
Sweden
Malmo University Hospital Recruiting
Malmo, Sweden
Principal Investigator: Timothy Resch, MD         
Switzerland
Centre Hospitalier Universitaire Vaudois Recruiting
Lausanne, Switzerland
Principal Investigator: Francois Saucy, MD         
UniversitätsSpital Zürich Recruiting
Zürich, Switzerland
Principal Investigator: Mario Lachat, MD         
United Kingdom
North Bristol NHS Trust - Southmead Hospital Withdrawn
Bristol, United Kingdom
The Royal Liverpool and NHS Broadgreen University Hospitals - Royal Liverpool University Hospital Recruiting
Liverpool, United Kingdom
Principal Investigator: Francesco Torella, MD         
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom
Principal Investigator: Colin Bicknell, MD         
Wythenshawe Hospital Recruiting
Manchester, United Kingdom
Principal Investigator: Jonathan Ghosh, MD         
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital Recruiting
Newcastle upon Tyne, United Kingdom
Principal Investigator: James McCaslin, MD         
Sponsors and Collaborators
Medtronic Endovascular
Investigators
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Principal Investigator: Jean-Paul de Vries, MD Universitair Medisch Centrum Groningen, Netherlands
Principal Investigator: William Jordan, MD Emory University, United States

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01534819     History of Changes
Other Study ID Numbers: Anchor Post Market Registry
First Posted: February 17, 2012    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Medtronic Endovascular:
Endograft
Endurant
Heli-FX™
EndoAnchor™
Short neck
Endovascular treatment
Interventional treatment of aortic aneurysm
Abdominal aortic aneurysm
AAA
Thoracic aortic aneurysm
TAA
Advanced disease
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases