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Search / Trial NCT01534819

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

Launched by MEDTRONIC CARDIOVASCULAR · Feb 14, 2012

Trial Information

Current as of July 22, 2025

Active, not recruiting

Keywords

Endograft Endurant Heli Fx™ Endo Anchor™ Short Neck Endovascular Treatment Interventional Treatment Of Aortic Aneurysm Abdominal Aortic Aneurysm Aaa Thoracic Aortic Aneurysm Taa Advanced Disease

ClinConnect Summary

The ANCHOR trial is a study that looks at a new treatment for people with aortic aneurysms, which are bulges in the aorta, the large blood vessel that carries blood from the heart. This trial focuses on using the Heli-FX™ EndoAnchor™ system to help secure a previously placed stent (a type of implant used to reinforce the aorta) and prevent problems like leaks or movement of the stent. People who might qualify for this study include adults over 18 who have an aortic aneurysm that is either asymptomatic (not causing symptoms) or symptomatic (causing symptoms), and who have had or will have a specific type of stent placed.

If you participate in the study, you'll be followed by your healthcare team for up to five years after your procedure to ensure everything is going well. Participants must be willing to attend regular follow-up appointments and provide informed consent, which means you agree to be part of the study after understanding what it involves. It's important to know that there are some conditions that may exclude you from this study, such as having a known allergy to the materials used in the treatment or being pregnant. The trial is currently active but not recruiting new participants.

Gender

ALL

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.

About Medtronic Cardiovascular

Medtronic Cardiovascular is a leading global healthcare technology company dedicated to transforming patient care through innovative medical solutions. With a focus on cardiovascular health, Medtronic develops advanced devices and therapies that address a wide range of heart and vascular conditions. Committed to clinical excellence and patient outcomes, the company conducts rigorous clinical trials to evaluate the safety and efficacy of its products, ensuring they meet the highest regulatory standards. Medtronic Cardiovascular strives to enhance the quality of life for patients worldwide while advancing the field of cardiovascular medicine through research and development.

Locations

Springfield, Illinois, United States

Durham, North Carolina, United States

Birmingham, Alabama, United States

Bronx, New York, United States

Lebanon, New Hampshire, United States

Norfolk, Virginia, United States

New York, New York, United States

Cleveland, Ohio, United States

Nashville, Tennessee, United States

Perth, , Australia

New Haven, Connecticut, United States

Charlotte, North Carolina, United States

Mountain View, California, United States

Baltimore, Maryland, United States

Albany, New York, United States

Stony Brook, New York, United States

Enschede, , Netherlands

Miami, Florida, United States

Zürich, , Switzerland

Tampa, Florida, United States

Perth, , Australia

Torrance, California, United States

Peoria, Illinois, United States

Orlando, Florida, United States

Arnhem, , Netherlands

Charleston, South Carolina, United States

Utrecht, , Netherlands

Rennes, , France

Manchester, , United Kingdom

Nieuwegein, , Netherlands

Berlin, , Germany

Little Rock, Arkansas, United States

Malmo, , Sweden

Auckland, , New Zealand

Lausanne, , Switzerland

West Columbia, South Carolina, United States

Valladolid, , Spain

Austin, Texas, United States

New York, New York, United States

Siena, , Italy

Memphis, Tennessee, United States

New York, New York, United States

Ludwigsburg, , Germany

London, , United Kingdom

Munich, , Germany

Heidelberg, , Germany

Seattle, Washington, United States

Barcelona, , Spain

Phoenix, Arizona, United States

Loma Linda, California, United States

Torrance, California, United States

Washington, District Of Columbia, United States

Atlanta, Georgia, United States

Honolulu, Hawaii, United States

Skokie, Illinois, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Flint, Michigan, United States

Royal Oak, Michigan, United States

Saint Louis, Missouri, United States

Queensbury, New York, United States

Asheville, North Carolina, United States

Chapel Hill, North Carolina, United States

Wormleysburg, Pennsylvania, United States

Chattanooga, Tennessee, United States

Temple, Texas, United States

Concord, , Australia

Dandenong, , Australia

St. Leonards, , Australia

Innsbruck, , Austria

Wien, , Austria

Strasbourg, , France

Aachen, , Germany

Leipzig, , Germany

Lingen, , Germany

Munich, , Germany

Munster, , Germany

Nuremberg, , Germany

Florence, , Italy

Roma, , Italy

Salerno, , Italy

Torino, , Italy

Rotterdam, , Netherlands

Nové Mesto, , Slovakia

Donostia / San Sebastián, , Spain

Liverpool, , United Kingdom

Newcastle Upon Tyne, , United Kingdom

Patients applied

0 patients applied

Trial Officials

Jean-Paul de Vries, MD

Principal Investigator

Universitair Medisch Centrum Groningen, Netherlands

William Jordan, MD

Principal Investigator

Augusta University Health, United States

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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