ANCHOR (Aneurysm Treatment Using the HeliFX Aortic Securement System Global Registry)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Aptus Endosystems
Sponsor:
Information provided by (Responsible Party):
Aptus Endosystems
ClinicalTrials.gov Identifier:
NCT01534819
First received: February 9, 2012
Last updated: August 28, 2012
Last verified: August 2012
  Purpose

Subjects who meet inclusion/exclusion criteria and who are treated with the Aptus HeliFX Aortic Securement 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 HeliFX Aortic Securement System is warranted.
  2. Revision Group- Those subjects who have previously undergone an EVAR procedure where the investigator believes that use of the EndoAnchor device 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: HeliFX Aortic Securement System
Procedure: AAA endograft placement
Device: Use of Aptus HeliFX Aortic Securement System (EndoAnchors)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Aneurysm Treatment Using the HeliFX 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 HeliFX Aortic Securement 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 EndoAnchors 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 EndoAnchor fracture


Estimated Enrollment: 2000
Study Start Date: April 2012
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2014 (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 HeliFX Aortic Securement System (EndoAnchors)
Device: HeliFX Aortic Securement System
Placement of 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 or 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.
Other Name: Endoanchors
Procedure: AAA endograft placement
Use of the Aptus HeliFX Aortic Securement System (EndoAnchors) during either primary placement or revision of a previously placed AAA endograft.
Other Names:
  • Endoanchors
  • Endografts
  • AAA
  • Percutaneous Abdominal aortic Aneurysm repair
Revision Group
Revision of a previously placed non-Aptus AAA endograft wth the concurrent use of Aptus HeliFX Aortic Securement System (EndoAnchors)
Device: HeliFX Aortic Securement System
Placement of 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 or 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.
Other Name: Endoanchors
Device: Use of Aptus HeliFX Aortic Securement System (EndoAnchors)
Placement of Aptus EndoAnchors during revision of a previously placed AAA endograft
Other Names:
  • Endoanchors
  • Endografts
  • AAA
  • Revision of AAA repair
  • Abdominal Aortic Aneurysm

  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 HeliFX 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 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 has already been implanted with an EndoAnchor 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 EndoAnchor penetration of the aortic wall
  • Use where, for whatever reason, each EndoAnchor 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: Esmeralda Sanjust 408.585.7328 esanjust@aptusendo.com
Contact: Lori Vivian, BSN 440-915-2381 lvivian@syntactx.com

  Show 19 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

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: August 28, 2012
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
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on September 18, 2014