ANCHOR (Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry)
- Conditions
- Aortic Aneurysm
- Interventions
- Device: EndoAnchor™Procedure: endovascular treament
- Registration Number
- NCT01534819
- Lead Sponsor
- Medtronic Cardiovascular
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1090
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Protocol B, abdominal arm, revision group endovascular treament AAA subjects with previously implanted commercial endografts for the treatment of graft migration and/or Type Ia endoleak Protocol B, abdominal arm, primary group endovascular treament 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. Protocol B, thoracic arm, revision group EndoAnchor™ 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 Protocol B, advanced disease arm, primary group endovascular treament 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. Protocol B, abdominal arm, revision group EndoAnchor™ AAA subjects with previously implanted commercial endografts for the treatment of graft migration and/or Type Ia endoleak Protocol B, thoracic arm, primary group endovascular treament 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 Protocol B, advanced disease arm, revision group endovascular treament 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 Protocol B, advanced disease arm, primary group EndoAnchor™ 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. Protocol C, abdominal arm, short neck, primary group EndoAnchor™ 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. Protocol B, thoracic arm, primary group EndoAnchor™ 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 Protocol B, abdominal arm, primary group EndoAnchor™ 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. Protocol C, abdominal arm, short neck, primary group endovascular treament 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. Protocol B, thoracic arm, revision group endovascular treament 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 Protocol B, advanced disease arm, revision group EndoAnchor™ 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
- Primary Outcome Measures
Name Time Method Protocol B has composite primary safety endpoints, tabulated separately for the abdominal, thoracic and advanced disease arms 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 aneurysmProtocol B has composite primary effectiveness endpoints, tabulated separately for the abdominal, thoracic and advanced disease arms 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 monthsProtocol C have composite primary effectiveness endpoint 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 monthsProtocol C has composite primary safety endpoint 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
- Secondary Outcome Measures
Name Time Method 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. 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™ fractureProtocol 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. 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
Trial Locations
- Locations (87)
Rijnstate Hospital
🇳🇱Arnhem, Netherlands
St. Antonius Hospital
🇳🇱Nieuwegein, Netherlands
Wythenshawe Hospital
🇬🇧Manchester, United Kingdom
VA Loma Linda Medical Center
🇺🇸Loma Linda, California, United States
El Camino Hospital
🇺🇸Mountain View, California, United States
Beth Israel Deaconess-Harvard
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Baptist Cardiac & Vascular Institute
🇺🇸Miami, Florida, United States
Harborview Medical Center, University of Washington
🇺🇸Seattle, Washington, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Park Hospital Leipzig
🇩🇪Leipzig, Germany
Klinikum Ludwigsburg
🇩🇪Ludwigsburg, Germany
Azienda Ospedaliero-Universitaria Careggi
🇮🇹Florence, Italy
Unihospital San Giovanni di Dio Ruggi d'Aragona
🇮🇹Salerno, Italy
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
St. Franzsikus-Hospital GmbH
🇩🇪Munster, Germany
University of Siena
🇮🇹Siena, Italy
Azienda Ospedaliera Ordine Mauriziano di Torino
🇮🇹Torino, Italy
Medisch Spectrum Twente
🇳🇱Enschede, Netherlands
UMC Utrecht
🇳🇱Utrecht, Netherlands
Auckland City Hospital
🇳🇿Auckland, New Zealand
Maimonides Medical Center
🇺🇸New York, New York, United States
Michigan Vascular Center
🇺🇸Flint, Michigan, United States
John L McClellan Memorial Veterans Hospital
🇺🇸Little Rock, Arkansas, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
A.ö. Landeskrankenhaus - Universitätskliniken Innsbruck
🇦🇹Innsbruck, Austria
Hôpital Pontchaillou
🇫🇷Rennes, France
LMU Kilinikum der Universitaet Muenchen
🇩🇪Munich, Germany
Johns Hopkins Bayview Medical Center
🇺🇸Baltimore, Maryland, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
MedStar Georgetown University Hospital Vascular Surgery Dept.
🇺🇸Washington, District of Columbia, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Abrazo Arizona Heart Institute
🇺🇸Phoenix, Arizona, United States
Allgemeines Krankenhaus - Universitätskliniken Wien
🇦🇹Wien, Austria
Baptist Memorial Hospital-Memphis
🇺🇸Memphis, Tennessee, United States
Southern Illinois University
🇺🇸Springfield, Illinois, United States
Klinikum Nuremberg
🇩🇪Nuremberg, Germany
Deutsches Herzzentrum
🇩🇪Berlin, Germany
University of South Florida
🇺🇸Tampa, Florida, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
University of California Irvine Medical Center
🇺🇸Torrance, California, United States
Harbor - UCLA Medical Center
🇺🇸Torrance, California, United States
HeartCare Midwest
🇺🇸Peoria, Illinois, United States
Evanston Hospital
🇺🇸Skokie, Illinois, United States
Albany Medical Center
🇺🇸Albany, New York, United States
Washington University School of Medicine, Barnes Jewish West County Hospital
🇺🇸Saint Louis, Missouri, United States
New York University Langone Medical Center
🇺🇸New York, New York, United States
The Mount Sinai Hospital
🇺🇸New York, New York, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
Vascular Health Partners
🇺🇸Queensbury, New York, United States
Mission Hospital
🇺🇸Asheville, North Carolina, United States
UPMC Pinnacle Harrisburg Campus
🇺🇸Wormleysburg, Pennsylvania, United States
Lexington Medical Center
🇺🇸West Columbia, South Carolina, United States
CHI Memorial Hospital Chattanooga
🇺🇸Chattanooga, Tennessee, United States
Concord Repatriation General Hospital
🇦🇺Concord, Australia
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Scott and White Medical Center
🇺🇸Temple, Texas, United States
Dandenong Hospital
🇦🇺Dandenong, Australia
Royal North Shore Hospital
🇦🇺St. Leonards, Australia
Sir Charles Gairdner Hospital
🇦🇺Perth, Australia
Nouvel Hôpital Civil
🇫🇷Strasbourg, France
Royal Perth Hospital
🇦🇺Perth, Australia
Medizinische Fakultät der RWTH
🇩🇪Aachen, Germany
University Hospital Heidelberg
🇩🇪Heidelberg, Germany
St. Bonifatius Hospital
🇩🇪Lingen, Germany
Technical University of Munich
🇩🇪Munich, Germany
AO Universitaria Policlinico
🇮🇹Roma, Italy
Maasstad Hospital Rotterdam
🇳🇱Rotterdam, Netherlands
Hospital Clínico Universitario de Valladolid
🇪🇸Valladolid, Spain
Malmo University Hospital
🇸🇪Malmo, Sweden
Thorax Institute Hospital Clinic
🇪🇸Barcelona, Spain
Narodny ustav srdcovych a cievnych chorob
🇸🇰Nové Mesto, Slovakia
Hospital Universitario Donostia
🇪🇸Donostia / San Sebastián, Spain
Centre Hospitalier Universitaire Vaudois
🇨🇭Lausanne, Switzerland
The Royal Liverpool and NHS Broadgreen University Hospitals - Royal Liverpool University Hospital
🇬🇧Liverpool, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
🇬🇧Newcastle upon Tyne, United Kingdom
Imperial College Healthcare NHS Trust
🇬🇧London, United Kingdom
UniversitätsSpital Zürich
🇨🇭Zürich, Switzerland
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Florida Hospital
🇺🇸Orlando, Florida, United States
University of North Carolina (UNC) Memorial Hospital
🇺🇸Chapel Hill, North Carolina, United States
Medical University of South Carolina (MUSC)
🇺🇸Charleston, South Carolina, United States
Kaiser Permanente Moanalua Medical Center and Clinic
🇺🇸Honolulu, Hawaii, United States
Cardiothoracic and Vascular Surgeons
🇺🇸Austin, Texas, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States