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

Status: Active_not_recruiting
Location: See all (88) locations...
Intervention Type: Procedure, Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Subjects with asymptomatic, symptomatic, or ruptured 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 followup evaluations

⁃ 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

⁃ 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)

⁃ 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

• 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

Locations
United States
Alabama
University of Alabama
Birmingham
Arkansas
John L McClellan Memorial Veterans Hospital
Little Rock
Arizona
Abrazo Arizona Heart Institute
Phoenix
California
VA Loma Linda Medical Center
Loma Linda
El Camino Hospital
Mountain View
Harbor - UCLA Medical Center
Torrance
University of California Irvine Medical Center
Torrance
Connecticut
Yale University School of Medicine
New Haven
Washington, D.c.
MedStar Georgetown University Hospital Vascular Surgery Dept.
Washington
Florida
Baptist Cardiac & Vascular Institute
Miami
Florida Hospital
Orlando
University of South Florida
Tampa
Georgia
Emory University Hospital
Atlanta
Hawaii
Kaiser Permanente Moanalua Medical Center and Clinic
Honolulu
Illinois
HeartCare Midwest
Peoria
Evanston Hospital
Skokie
Southern Illinois University
Springfield
Massachusetts
Beth Israel Deaconess-Harvard
Boston
Maryland
Johns Hopkins Bayview Medical Center
Baltimore
University of Maryland Medical Center
Baltimore
Michigan
Michigan Vascular Center
Flint
William Beaumont Hospital
Royal Oak
Missouri
Washington University School of Medicine, Barnes Jewish West County Hospital
Saint Louis
North Carolina
Mission Hospital
Asheville
University of North Carolina (UNC) Memorial Hospital
Chapel Hill
Carolinas Medical Center
Charlotte
Duke University Medical Center
Durham
New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon
New York
Albany Medical Center
Albany
Montefiore Medical Center
Bronx
Maimonides Medical Center
New York
New York University Langone Medical Center
New York
The Mount Sinai Hospital
New York
Vascular Health Partners
Queensbury
Stony Brook University Medical Center
Stony Brook
Ohio
Cleveland Clinic
Cleveland
Pennsylvania
UPMC Pinnacle Harrisburg Campus
Wormleysburg
South Carolina
Medical University of South Carolina (MUSC)
Charleston
Lexington Medical Center
West Columbia
Tennessee
CHI Memorial Hospital Chattanooga
Chattanooga
Baptist Memorial Hospital-Memphis
Memphis
Vanderbilt University Medical Center
Nashville
Texas
Cardiothoracic and Vascular Surgeons
Austin
Scott and White Medical Center
Temple
Virginia
Sentara Norfolk General Hospital
Norfolk
Washington
Harborview Medical Center, University of Washington
Seattle
Other Locations
Australia
Concord Repatriation General Hospital
Concord
Dandenong Hospital
Dandenong
Royal Perth Hospital
Perth
Sir Charles Gairdner Hospital
Perth
Royal North Shore Hospital
St. Leonards
Austria
A.ö. Landeskrankenhaus - Universitätskliniken Innsbruck
Innsbruck
Allgemeines Krankenhaus - Universitätskliniken Wien
Wien
France
Hôpital Pontchaillou
Rennes
Nouvel Hôpital Civil
Strasbourg
Germany
Medizinische Fakultät der RWTH
Aachen
Deutsches Herzzentrum
Berlin
University Hospital Heidelberg
Heidelberg
Park Hospital Leipzig
Leipzig
St. Bonifatius Hospital
Lingen
Klinikum Ludwigsburg
Ludwigsburg
LMU Kilinikum der Universitaet Muenchen
Munich
Technical University of Munich
Munich
St. Franzsikus-Hospital GmbH
Munster
Klinikum Nuremberg
Nuremberg
Italy
Azienda Ospedaliero-Universitaria Careggi
Florence
AO Universitaria Policlinico
Roma
Unihospital San Giovanni di Dio Ruggi d'Aragona
Salerno
University of Siena
Siena
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino
Netherlands
Rijnstate Hospital
Arnhem
Medisch Spectrum Twente
Enschede
St. Antonius Hospital
Nieuwegein
Maasstad Hospital Rotterdam
Rotterdam
UMC Utrecht
Utrecht
New Zealand
Auckland City Hospital
Auckland
Auckland City Hospital
Auckland
Slovakia
Narodny ustav srdcovych a cievnych chorob
Nové Mesto
Spain
Thorax Institute Hospital Clinic
Barcelona
Hospital Universitario Donostia
Donostia / San Sebastián
Hospital Clínico Universitario de Valladolid
Valladolid
Sweden
Malmo University Hospital
Malmo
Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne
UniversitätsSpital Zürich
Zürich
United Kingdom
The Royal Liverpool and NHS Broadgreen University Hospitals - Royal Liverpool University Hospital
Liverpool
Imperial College Healthcare NHS Trust
London
Wythenshawe Hospital
Manchester
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Newcastle Upon Tyne
Time Frame
Start Date: 2012-04
Completion Date: 2025-12-03
Participants
Target number of participants: 1090
Treatments
Protocol B, abdominal arm, revision group
AAA subjects with previously implanted commercial endografts for the treatment of graft migration and/or Type Ia endoleak
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.
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
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
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
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Medtronic Cardiovascular

This content was sourced from clinicaltrials.gov

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