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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EndoAnchor™ | Device | Use of the EndoAnchor™ in conjunction with endograft |
|
| Measure | Description | Time Frame |
|---|---|---|
| Protocol B has composite primary safety endpoints, tabulated separately for the abdominal, thoracic and advanced disease arms | 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 | 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 | The primary safety endpoint is defined by:
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 | 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:
| Through 12 months |
| 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. |
|
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Protocol B:
Inclusion criteria:
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:
Subject's iliac/femoral access is compatible with:
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:
Protocol C:
Inclusion criteria:
Exclusion criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Paul de Vries, MD | Universitair Medisch Centrum Groningen, Netherlands | Principal Investigator |
| William Jordan, MD | Augusta University Health, United States | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | United States | ||
| Abrazo Arizona Heart Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25088739 | Result | 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. | |
| 26069087 |
| Label | URL |
|---|---|
| Medtronic | View source |
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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. |
|
|
| endovascular treament | Procedure | implantation of a device inserted through an artery |
|
| 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. |
| Through 5 years |
| Phoenix |
| Arizona |
| 84006 |
| United States |
| John L McClellan Memorial Veterans Hospital | Little Rock | Arkansas | 72205 | United States |
| VA Loma Linda Medical Center | Loma Linda | California | 92357 | United States |
| El Camino Hospital | Mountain View | California | 94040 | United States |
| University of California Irvine Medical Center | Torrance | California | 90502-2004 | United States |
| Harbor - UCLA Medical Center | Torrance | California | 90509 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | United States |
| MedStar Georgetown University Hospital Vascular Surgery Dept. | Washington D.C. | District of Columbia | 20007 | United States |
| Baptist Cardiac & Vascular Institute | Miami | Florida | 33176 | United States |
| Florida Hospital | Orlando | Florida | 32751 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322-1059 | United States |
| Kaiser Permanente Moanalua Medical Center and Clinic | Honolulu | Hawaii | 96819 | United States |
| HeartCare Midwest | Peoria | Illinois | 61614 | United States |
| Evanston Hospital | Skokie | Illinois | 60077 | United States |
| Southern Illinois University | Springfield | Illinois | 62702 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21401 | United States |
| Beth Israel Deaconess-Harvard | Boston | Massachusetts | 02215 | United States |
| Michigan Vascular Center | Flint | Michigan | 98507 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48703 | United States |
| Washington University School of Medicine, Barnes Jewish West County Hospital | St Louis | Missouri | 63110 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| New York University Langone Medical Center | New York | New York | 10016 | United States |
| The Mount Sinai Hospital | New York | New York | 10029 | United States |
| Maimonides Medical Center | New York | New York | 11219 | United States |
| Vascular Health Partners | Queensbury | New York | 12804 | United States |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Mission Hospital | Asheville | North Carolina | 28806 | United States |
| University of North Carolina (UNC) Memorial Hospital | Chapel Hill | North Carolina | 27599 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| UPMC Pinnacle Harrisburg Campus | Wormleysburg | Pennsylvania | 17043 | United States |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | United States |
| Lexington Medical Center | West Columbia | South Carolina | 29169 | United States |
| CHI Memorial Hospital Chattanooga | Chattanooga | Tennessee | 37403 | United States |
| Baptist Memorial Hospital-Memphis | Memphis | Tennessee | 38120 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Cardiothoracic and Vascular Surgeons | Austin | Texas | 78756 | United States |
| Scott and White Medical Center | Temple | Texas | 76508 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
| Harborview Medical Center, University of Washington | Seattle | Washington | 98104 | United States |
| Concord Repatriation General Hospital | Concord | NSW 2139 | Australia |
| Dandenong Hospital | Dandenong | VIC 3175 | Australia |
| Royal Perth Hospital | Perth | WA 6000 | Australia |
| Sir Charles Gairdner Hospital | Perth | Australia |
| Royal North Shore Hospital | St Leonards | NSW 2065 | Australia |
| A.ö. Landeskrankenhaus - Universitätskliniken Innsbruck | Innsbruck | Austria |
| Allgemeines Krankenhaus - Universitätskliniken Wien | Vienna | Austria |
| Hôpital Pontchaillou | Rennes | France |
| Nouvel Hôpital Civil | Strasbourg | France |
| Medizinische Fakultät der RWTH | Aachen | Germany |
| Deutsches Herzzentrum | Berlin | Germany |
| University Hospital Heidelberg | Heidelberg | Germany |
| Park Hospital Leipzig | Leipzig | Germany |
| St. Bonifatius Hospital | Lingen | Germany |
| Klinikum Ludwigsburg | Ludwigsburg | Germany |
| LMU Kilinikum der Universitaet Muenchen | Munich | Germany |
| Technical University of Munich | Munich | Germany |
| St. Franzsikus-Hospital GmbH | Münster | Germany |
| Klinikum Nuremberg | Nuremberg | Germany |
| Azienda Ospedaliero-Universitaria Careggi | Florence | Italy |
| AO Universitaria Policlinico | Roma | Italy |
| Unihospital San Giovanni di Dio Ruggi d'Aragona | Salerno | 84131 | Italy |
| University of Siena | Siena | Italy |
| Azienda Ospedaliera Ordine Mauriziano di Torino | Torino | Italy |
| Rijnstate Hospital | Arnhem | Netherlands |
| Medisch Spectrum Twente | Enschede | Netherlands |
| St. Antonius Hospital | Nieuwegein | Netherlands |
| Maasstad Hospital Rotterdam | Rotterdam | Netherlands |
| UMC Utrecht | Utrecht | Netherlands |
| Auckland City Hospital | Auckland | 1023 | New Zealand |
| Narodny ustav srdcovych a cievnych chorob | Nové Mesto | Slovakia |
| Thorax Institute Hospital Clinic | Barcelona | Spain |
| Hospital Universitario Donostia | Donostia / San Sebastian | Spain |
| Hospital Clínico Universitario de Valladolid | Valladolid | Spain |
| Malmo University Hospital | Malmö | Sweden |
| Centre Hospitalier Universitaire Vaudois | Lausanne | Switzerland |
| UniversitätsSpital Zürich | Zurich | Switzerland |
| The Royal Liverpool and NHS Broadgreen University Hospitals - Royal Liverpool University Hospital | Liverpool | United Kingdom |
| Imperial College Healthcare NHS Trust | London | United Kingdom |
| Wythenshawe Hospital | Manchester | United Kingdom |
| The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital | Newcastle upon Tyne | United Kingdom |
| Result |
| 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. |
| 37558144 | Derived | Arko FR 3rd, Pearce BJ, Henretta JP, Fugate MW, Torsello G, Panneton JM, Peng Y, Edward Garrett H Jr. Five-year outcomes of endosuture aneurysm repair in patients with short neck abdominal aortic aneurysm from the ANCHOR registry. J Vasc Surg. 2023 Dec;78(6):1418-1425.e1. doi: 10.1016/j.jvs.2023.07.058. Epub 2023 Aug 7. |
| 30907259 | Derived | 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. |
| 30850297 | Derived | 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. |
| 29248241 | Derived | 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. |
| 25809354 | Derived | 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. |
| 25735260 | Derived | 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. |
| 25284629 | Derived | 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. |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D017544 | Aortic Aneurysm, Abdominal |
| D017545 | Aortic Aneurysm, Thoracic |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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