Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

ANCHOR (Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry) (ANCHOR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Medtronic Endovascular
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT01534819
First received: February 9, 2012
Last updated: May 22, 2017
Last verified: January 2017
  Purpose

Subjects who meet inclusion/exclusion criteria and who are treated with the Aptus Heli-FX EndoAnchor System in conjunction with commercially available non-Aptus Endografts will be divided, as appropriate, into two groups.

  1. Primary Group- Subjects undergoing initial (primary) endovascular repair of an AAA where the investigator believes the proximal aortic neck is challenging such that the risk of failure or fixation and/or sealing is great enough so that the use of the Heli-FX EndoAnchor System is warranted.
  2. Revision Group- Those subjects who have previously undergone an EVAR procedure where the investigator believes that use of the Heli-FX EndoAnchor System is warranted to A- Treat existing graft migration and/or type 1a endoleak, with or without the concurrent use of other devices. B- Treat subjects believed to be at risk for migration and/or Type 1a endoleak

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 Intervention
Abdominal Aortic Aneurysm
Device: Aptus Heli-FX EndoAnchor System
Procedure: AAA/TAA endograft placement

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry

Resource links provided by NLM:


Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • The Registry has composite Primary Efficacy Endpoints and composite Primary Safety endpoints, tabulated separately for the abdominal, thoracic, and advanced disease arms. [ Time Frame: 1 year ]

    The primary efficacy endpoint requires all of the following:

    i. successful implantation of the minimum number of EndoAnchors™; the number defined by the diameter per the instructions for use (abdominal arm only), and ii. freedom from migration at 12 months following the index procedure, where migration is defined as >10mm movement of the aortic endograft from its position at the 1-month CT, and iii. freedom from Type I endoleak at the targeted attachment site(s) at 12 months following the index procedure.

    The primary safety endpoint is defined by:

    i. freedom from device-related serious adverse events at 12 months following the index procedure, and ii. freedom from procedure-related serious adverse events at 12 months following the index procedure.

    iii. Freedom from aneurysm-related mortality, defined as:

    • Death within 30 days of the index procedure
    • death within 30 days of any secondary procedure to address the aneurysm
    • death from rupture of the treated aneurysm


Secondary Outcome Measures:
  • Clinical Success (reflecting the clinical performance and Safety of the Aptus Heli-FX EndoAnchor System) and frequency of aneurysm-related secondary interventions. [ Time Frame: Through 12 months ]

    Clinical Success is defined as the successful implantation of the suggested number of EndoAnchors 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 arm only)
    • Endograft infection
    • Endograft migration- defined as >10mm movement of any component treated with EndoAnchors compared to the 30-day imaging study
    • Loss of endograft fabric integrity as a result of the EndoAnchor
    • Rupture of the treated aneurysm
    • Conversion to open surgical repair

    Other outcomes

    • Secondary aneurysm-related interventions after EndoAnchor implantation
    • All cause mortality
    • Freedom from EndoAnchor fracture


Estimated Enrollment: 2000
Actual Study Start Date: April 2012
Estimated Study Completion Date: April 2024
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Primary Group
Initial placement of a commercially available AAA/TAA endograft with the concurrent use of Aptus Heli-FX™ EndoAnchor System (Heli-FX)
Device: Aptus Heli-FX EndoAnchor System
Placement of the Aptus Heli-FX™ EndoAnchor System in subjects for the prevention of graft migration and the treatment of Type Ia endoleak or Aptus Heli-FX EndoAnchor System placed 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.
Other Names:
  • EndoAnchors
  • Heli-FX
Procedure: AAA/TAA endograft placement
Use of the Aptus Heli-FX EndoAnchor System (Heli-FX) during either primary placement of a AAA/TAA endograft.
Other Names:
  • EndoAnchors
  • Endografts
  • AAA/TAA
  • Abdominal/Thoracic aortic Aneurysm repair
  • Heli-FX
Revision Group
Revision of a previously placed Aptus AAA/TAA endograft with the concurrent use of Aptus Heli-FX™ EndoAnchor System (Heli-FX)
Device: Aptus Heli-FX EndoAnchor System
Placement of the Aptus Heli-FX™ EndoAnchor System in subjects for the prevention of graft migration and the treatment of Type Ia endoleak or Aptus Heli-FX EndoAnchor System placed 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.
Other Names:
  • EndoAnchors
  • Heli-FX

Detailed Description:

Study Arms:

Abdominal Arm: Subjects with abdominal aortic aneurysms that do not require placement of EndoAnchors™ above the level of the renal arteries will be considered part of the abdominal arm. If a renal artery or any visceral artery requires (a) chimney procedure(s), the subject will be considered part of the Advanced Disease arm.

Thoracic Arm: Subjects with thoracic aortic aneurysms that do not require placement of any EndoAnchors proximal to the left common carotid artery (LCCA) or distal to the celiac artery. Thoracic procedures which require arch vessel transposition(s) or bypass procedures to the LCCA or brachiocephalic artery, chimney procedures into any arch or visceral artery(s), or hybrid open-endovascular repairs to the aorta will be considered part of the Advanced Disease Arm.

Advanced Disease Arm: To collect data on consecutively treated patients, the Advanced Disease Arm will be comprised of subjects that required placement of EndoAnchors proximal to the LCCA or in the visceral segment of the aorta distal to the celiac artery and proximal to the renal arteries. Subjects with thoracic procedures which require arch vessel transposition(s) or bypass (except to the left subclavian artery) or hybrid open-endovascular procedures as well as those with abdominal or thoracic procedures that require chimney procedures into any renal or visceral artery should also be included in the Advanced Disease arm.

Primary Group: Assess the Aptus HeliFX Aortic Securement System placed 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.

Revision Group: Assess the Aptus HeliFX™ Aortic Securement System in subjects with previously implanted commercial endografts, for the prevention of graft migration and the treatment of Type Ia endoleak.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects undergoing primary placement of an approved endograft to treat an abdominal aortic aneurysm or subjects undergoing revision of a previously placed abdominal aortic endograft.
Criteria

Inclusion Criteria:

  • Subjects with asymptomatic, symptomatic, or ruptured abdominal 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 follow-up evaluations
  • Subject has a previously implanted endograft (Revision Group), or will be undergoing repair (Primary Group), 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 the Aptus Heli-FX EndoAnchor System in the Instructions for Use
  • Subject's iliac/femoral access is compatible
  • a 16 French sheath (abdominal subjects)
  • 18 French seath (thoracic subjects)
  • Selected 16 or 18 French sheath, as applicable to the device selected for use (advanced disease subjects)
  • Subject has a previously implanted endograft that has migrated or has a Type Ia endoleak within the aorta (Revision Group) or will undergo implantation of an endograft that in the opinion of the Investigator will be at increased risk of such complications (Primary Group)

Exclusion Criteria:

  • Subject has known allergy to the EndoAnchor implant material (nickel, chromium, molybdenum, or cobalt)
  • Subject has a life expectancy 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 treated with EndoAnchors in the same segment of the aorta that will be treated in the registry
  • 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 implantation that precludes adequate EndoAnchor penetration of the aortic wall
  • Use where, for whatever reason, each EndoAnchor is not anticipated to adequately penetrate into the aortic wall
  • Subject has an aortic dissection that invloves an area to be treated with EndoAnchors
  • Subject has Marfan Syndrome, Ehlers Danlos Syndrome, or another collagen vascular disease
  • Subject is pregnant
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01534819

Contacts
Contact: Karla Betz karla.h.betz@medtronic.com
Contact: Roy Jentjens roy.jentjens@medtronic.com

  Show 60 Study Locations
Sponsors and Collaborators
Medtronic Endovascular
Investigators
Principal Investigator: Jean-Paul de Vries, MD St Antonius Hospital - Nieuwegein, Netherlands
Principal Investigator: William Jordan, MD Emory University
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01534819     History of Changes
Other Study ID Numbers: Anchor Post Market Registry
Study First Received: February 9, 2012
Last Updated: May 22, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Medtronic Endovascular:
Abdominal aortic aneurysm
AAA
Endograft
interventional treatment of AAA

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on May 25, 2017