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

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ClinicalTrials.gov Identifier: NCT01534819
Recruitment Status : Recruiting
First Posted : February 17, 2012
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

Tracking Information
First Submitted Date February 9, 2012
First Posted Date February 17, 2012
Last Update Posted Date June 18, 2019
Actual Study Start Date April 2012
Estimated Primary Completion Date April 2022   (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 ]
Change History Complete list of historical versions of study NCT01534819 on ClinicalTrials.gov Archive Site
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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 13, 2019)
1200
Original Estimated Enrollment
 (submitted: February 14, 2012)
2000
Estimated Study Completion Date April 2028
Estimated Primary Completion Date April 2022   (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: Michelle Endo michelle.m.endo@medtronic.com
Contact: Rakel Alexandersdottir rakel.alexandersdottir@medtronic.com
Listed Location Countries Australia,   Austria,   France,   Germany,   Italy,   Netherlands,   New Zealand,   Poland,   Slovakia,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
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
Responsible Party Medtronic Endovascular
Study Sponsor Medtronic Endovascular
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 Endovascular
Verification Date June 2019