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

Aortic Aneurysm Clinical Trial

— ANCHOR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01534819
• Other study ID #: Anchor Post Market Registry
• Status: Active, not recruiting
• Start date: April 2012
• Est. completion date: December 3, 2025

Study information

• Verified date: March 2024
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 1090
• Est. completion date: December 3, 2025
• Est. primary completion date: December 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm

Intervention

Device:
• EndoAnchor™
Use of the EndoAnchor™ in conjunction with endograft

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

Locations

Country	Name	City	State
Australia	Concord Repatriation General Hospital	Concord
Australia	Dandenong Hospital	Dandenong
Australia	Royal Perth Hospital	Perth
Australia	Sir Charles Gairdner Hospital	Perth
Australia	Royal North Shore Hospital	St. Leonards
Austria	A.ö. Landeskrankenhaus - Universitätskliniken Innsbruck	Innsbruck
Austria	Allgemeines Krankenhaus - Universitätskliniken Wien	Wien
France	Hôpital Pontchaillou	Rennes
France	Nouvel Hôpital Civil	Strasbourg
Germany	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	Munster
Germany	Klinikum Nuremberg	Nuremberg
Italy	Azienda Ospedaliero-Universitaria Careggi	Florence
Italy	AO Universitaria Policlinico	Roma
Italy	Unihospital San Giovanni di Dio Ruggi d'Aragona	Salerno
Italy	University of Siena	Siena
Italy	Azienda Ospedaliera Ordine Mauriziano di Torino	Torino
Netherlands	Rijnstate Hospital	Arnhem
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	St. Antonius Hospital	Nieuwegein
Netherlands	Maasstad Hospital Rotterdam	Rotterdam
Netherlands	UMC Utrecht	Utrecht
New Zealand	Auckland City Hospital	Auckland
New Zealand	Auckland City Hospital	Auckland
Slovakia	Narodny ustav srdcovych a cievnych chorob	Nové Mesto
Spain	Thorax Institute Hospital Clinic	Barcelona
Spain	Hospital Universitario Donostia	Donostia / San Sebastián
Spain	Hospital Clínico Universitario de Valladolid	Valladolid
Sweden	Malmo University Hospital	Malmo
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
Switzerland	UniversitätsSpital Zürich	Zürich
United Kingdom	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 States	Albany Medical Center	Albany	New York
United States	Mission Hospital	Asheville	North Carolina
United States	Emory University Hospital	Atlanta	Georgia
United States	Cardiothoracic and Vascular Surgeons	Austin	Texas
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	University of Alabama	Birmingham	Alabama
United States	Beth Israel Deaconess-Harvard	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
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	Carolinas Medical Center	Charlotte	North Carolina
United States	CHI Memorial Hospital Chattanooga	Chattanooga	Tennessee
United States	Cleveland Clinic	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Michigan Vascular Center	Flint	Michigan
United States	Kaiser Permanente Moanalua Medical Center and Clinic	Honolulu	Hawaii
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	John L McClellan Memorial Veterans Hospital	Little Rock	Arkansas
United States	VA Loma Linda Medical Center	Loma Linda	California
United States	Baptist Memorial Hospital-Memphis	Memphis	Tennessee
United States	Baptist Cardiac & Vascular Institute	Miami	Florida
United States	El Camino Hospital	Mountain View	California
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Maimonides Medical Center	New York	New York
United States	New York University Langone Medical Center	New York	New York
United States	The Mount Sinai Hospital	New York	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Florida Hospital	Orlando	Florida
United States	HeartCare Midwest	Peoria	Illinois
United States	Abrazo Arizona Heart Institute	Phoenix	Arizona
United States	Vascular Health Partners	Queensbury	New York
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Washington University School of Medicine, Barnes Jewish West County Hospital	Saint Louis	Missouri
United States	Harborview Medical Center, University of Washington	Seattle	Washington
United States	Evanston Hospital	Skokie	Illinois
United States	Southern Illinois University	Springfield	Illinois
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	University of South Florida	Tampa	Florida
United States	Scott and White Medical Center	Temple	Texas
United States	Harbor - UCLA Medical Center	Torrance	California
United States	University of California Irvine Medical Center	Torrance	California
United States	MedStar Georgetown University Hospital Vascular Surgery Dept.	Washington	District of Columbia
United States	Lexington Medical Center	West Columbia	South Carolina
United States	UPMC Pinnacle Harrisburg Campus	Wormleysburg	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiovascular

Countries where clinical trial is conducted

United States,  Australia,  Austria,  France,  Germany,  Italy,  Netherlands,  New Zealand,  Slovakia,  Spain,  Sweden,  Switzerland,  United Kingdom, 

References & Publications (2)

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 — View Citation

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 End — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Protocol C has composite primary safety endpoint	The primary safety endpoint is defined by: device-related serious adverse events at 12 months; 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
Primary	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: migration at 12 months and; Type I endoleak at the targeted attachment site(s) at 12 months	Through 12 months
Secondary	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.	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; 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; Secondary aneurysm-related interventions after EndoAnchor™ implantation; all-cause mortality; Freedom from EndoAnchor™ fracture	Through 5 years
Secondary	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.	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; 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; Secondary aneurysm-related interventions after EndoAnchor™ implantation; all-cause mortality; EndoAnchor™ implant fracture	Through 5 years

External Links

•   Medtronic