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

• ClinicalTrials.gov Identifier: NCT01534819
• Recruitment Status: Active, not recruiting
• First Posted: February 17, 2012
• Last Update Posted: May 17, 2023
• Sponsor: Medtronic Cardiovascular
• Information provided by (Responsible Party): Medtronic Cardiovascular

Tracking Information

• First Submitted Date: February 9, 2012
• First Posted Date: February 17, 2012
• Last Update Posted Date: May 17, 2023
• Actual Study Start Date: April 2012
• Actual Primary Completion Date: December 3, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 13, 2019)

• 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
• 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
• 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
• 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

Original Primary Outcome Measures (submitted: February 14, 2012)

• Freedom from device related serious adverse events following the index procedure [ Time Frame: 1 year ]
• Freedom from procedural related serious adverse events following index procedure [ Time Frame: 1 year ]

Current Secondary Outcome Measures (submitted: June 13, 2019)

• 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
• 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

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: ANCHOR (Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry)
• Official Title: Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry

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.
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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

• Condition: Aortic Aneurysm

Intervention

• 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

Study Groups/Cohorts

• Protocol B, abdominal arm, revision group
  AAA subjects with previously implanted commercial endografts for the treatment of graft migration and/or Type Ia endoleak
  Interventions:

  • Device: EndoAnchor™
  • Procedure: endovascular treament
• 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.
  Interventions:

  • Device: EndoAnchor™
  • Procedure: endovascular treament
• 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
  Interventions:

  • Device: EndoAnchor™
  • Procedure: endovascular treament
• 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
  Interventions:

  • Device: EndoAnchor™
  • Procedure: endovascular treament
• 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
  Interventions:

  • Device: EndoAnchor™
  • Procedure: endovascular treament
• 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.
  Interventions:

  • Device: EndoAnchor™
  • Procedure: endovascular treament
• 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.
  Interventions:

  • Device: EndoAnchor™
  • Procedure: endovascular treament

Publications *

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: January 22, 2020): 1090
• Original Estimated Enrollment (submitted: February 14, 2012): 2000
• Estimated Study Completion Date: December 3, 2024
• Actual Primary Completion Date: December 3, 2020 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Austria, France, Germany, Italy, Netherlands, New Zealand, Slovakia, Spain, Sweden, Switzerland, United Kingdom, United States
• Removed Location Countries: Poland

Administrative Information

• NCT Number: NCT01534819
• Other Study ID Numbers: Anchor Post Market Registry
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Medtronic Cardiovascular
• Original Responsible Party: Aptus Endosystems
• Current Study Sponsor: Medtronic Cardiovascular
• Original Study Sponsor: Aptus Endosystems
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jean-Paul de Vries, MD; Universitair Medisch Centrum Groningen, Netherlands
• Principal Investigator: William Jordan, MD; Emory University, United States

• PRS Account: Medtronic Cardiovascular
• Verification Date: May 2023