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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Aptus Endosystems
Sponsor:
Information provided by (Responsible Party):
Aptus Endosystems
ClinicalTrials.gov Identifier:
NCT01534819
First received: February 9, 2012
Last updated: November 17, 2014
Last verified: November 2014
  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 IFC 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 recommendations.


Condition Intervention
Abdominal Aortic Aneurysm
Device: Heli-FX EndoAnchor System
Procedure: AAA endograft placement
Device: Use of Aptus Heli-FX EndoAnchor System (Heli-FX)

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 Aptus Endosystems:

Primary Outcome Measures:
  • Freedom from device related serious adverse events following the index procedure [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Freedom from procedural related serious adverse events following index procedure [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

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

    Clinical Success defined as successful implantation of suggested number of Heli-FX at index procedure and absence of:

    • Death as a result of aneurysm-related treatment
    • Type I endoleak
    • Endograft infection
    • Endograft migration (>10mm)
    • Loss of integrity
    • Aneurysm rupture
    • Conversion to open repair

    Other outcomes

    • Secondary Interventions
    • Aneurysm-related events
    • All cause mortality
    • Freedom from Heli-FX fracture


Estimated Enrollment: 2000
Study Start Date: April 2012
Estimated Study Completion Date: March 2021
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Primary Group
Initial placement of an FDA approved AAA endograft with the concurrent use of Heli-FX™ EndoAnchor System (Heli-FX)
Device: Heli-FX EndoAnchor System
Placement of the Aptus Heli-FX™ EndoAnchor System in subjects with previously implanted commercial endografts, 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 endograft placement
Use of the Aptus Heli-FX EndoAnchor System (Heli-FX) during either primary placement or revision of a previously placed AAA endograft.
Other Names:
  • EndoAnchors
  • Endografts
  • AAA
  • Percutaneous Abdominal aortic Aneurysm repair
  • Heli-FX
Revision Group
Revision of a previously placed non-Aptus AAA endograft wth the concurrent use of Aptus Heli-FX™ EndoAnchor System (Heli-FX)
Device: Heli-FX EndoAnchor System
Placement of the Aptus Heli-FX™ EndoAnchor System in subjects with previously implanted commercial endografts, 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
Device: Use of Aptus Heli-FX EndoAnchor System (Heli-FX)
Placement of Heli-FX during revision of a previously placed AAA endograft
Other Names:
  • EndoAnchor
  • Endografts
  • AAA
  • Revision of AAA repair
  • Abdominal Aortic Aneurysm
  • Heli-FX

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 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 abdominal aortic aneurysm endograft devices:

    • Cook Zenith
    • Gore Excluder
    • Medtronic AneuRx
    • Medtronic Talent
    • Medtronic Endurant
    • Any additional third party AAA endograft device that is commercially available and listed as compatible with the Heli-FX EndoAnchor System in the Instructions for Use
  • Subject's iliac/femoral access is compatible a 16 French sheath
  • Subject has a previously implanted endograft that has migrated or has a Type Ia endoleak (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 Heli-FX 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 has already been implanted with a Heli-FX device in a procedure performed prior to the index procedure
  • 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)
  • Infrarenal aortic neck with significant thrombus or calcium that precludes adequate Heli-FX penetration of the aortic wall
  • Use where, for whatever reason, each Heli-FX is not anticipated to adequately penetrate into the aortic wall.
  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: Irene Kuhn 212.266.0126 ikuhn@syntactx.com
Contact: Joni Yabut 408.585.7358 jyabut@aptusendo.com

  Show 56 Study Locations
Sponsors and Collaborators
Aptus Endosystems
Investigators
Principal Investigator: Jean-Paul de Vries, MD St Antonius Hospital - Nieuwegein, Netherlands
Principal Investigator: William Jordan, MD University of Alabama - Birmingham, AL
  More Information

Additional Information:
No publications provided

Responsible Party: Aptus Endosystems
ClinicalTrials.gov Identifier: NCT01534819     History of Changes
Other Study ID Numbers: Anchor Post Market Registry
Study First Received: February 9, 2012
Last Updated: November 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Aptus Endosystems:
Abdominal aortic aneurysm
AAA
Endograft
interventional treatment of AAA

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

ClinicalTrials.gov processed this record on November 25, 2014