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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
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
Similar Trials