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Trial record 1 of 1 for:    NCT01534819
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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

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.


Condition or disease Intervention/treatment
Aortic Aneurysm Device: EndoAnchor™ Procedure: endovascular treament

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.

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry
Actual Study Start Date : April 2012
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2028

Resource links provided by the National Library of Medicine


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

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.
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

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
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

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
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

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
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

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.
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

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.
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




Primary Outcome Measures :
  1. 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


  2. 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


  3. 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


  4. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01534819


Contacts
Layout table for location contacts
Contact: Michelle Endo michelle.m.endo@medtronic.com
Contact: Rakel Alexandersdottir rakel.alexandersdottir@medtronic.com

  Show 97 Study Locations
Sponsors and Collaborators
Medtronic Endovascular
Investigators
Layout table for investigator information
Principal Investigator: Jean-Paul de Vries, MD Universitair Medisch Centrum Groningen, Netherlands
Principal Investigator: William Jordan, MD Emory University, United States

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01534819     History of Changes
Other Study ID Numbers: Anchor Post Market Registry
First Posted: February 17, 2012    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Medtronic Endovascular:
Endograft
Endurant
Heli-FX™
EndoAnchor™
Short neck
Endovascular treatment
Interventional treatment of aortic aneurysm
Abdominal aortic aneurysm
AAA
Thoracic aortic aneurysm
TAA
Advanced disease

Additional relevant MeSH terms:
Layout table for MeSH terms
Aneurysm
Aortic Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases