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



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/6/2019
Start Date:April 2012
End Date:April 2024
Contact:Anna Busman
Email:anna.busman@medtronic.com

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

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.

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.

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
We found this trial at
49
sites
1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Mark Fillinger, MD
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lebanon, NH
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Evan C Lipsitz, MD
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
Principal Investigator: Frank Arko, MD
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Charlotte, NC
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Matthew Eagleton, MD
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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8900 North Kendall Drive
Miami, Florida 33176
Principal Investigator: Ripal Gandhi, MD
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Miami, FL
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Thomas C Naslund, MD
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
Principal Investigator: Murray Shames, MD
University of South Florida The University of South Florida is a high-impact, global research university...
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Tampa, FL
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Albany, New York 12208
Principal Investigator: Jeffrey Hnath, MD
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Albany, NY
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Asheville, North Carolina 28801
Principal Investigator: John Henretta, MD
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Asheville, NC
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Principal Investigator: William Jordan, MD
Emory University Hospital As the largest health care system in Georgia and the only health...
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Atlanta, GA
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Austin, Texas 78756
Principal Investigator: Mazin Foteh
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Austin, TX
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
Principal Investigator: Shahab Toursavadkohi
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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Baltimore, MD
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4940 Eastern Ave
Baltimore, Maryland 21224
(410) 550-0100
Principal Investigator: Mahmoud Malas, MD
Johns Hopkins Bayview Medical Center There is no better story in American medicine in the...
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Baltimore, MD
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Birmingham, Alabama 35294
Principal Investigator: Benjamin Pearce, MD
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Boston, Massachusetts
Principal Investigator: Marc Schermerhorn, MD
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Boston, MA
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Chapel Hill, North Carolina 27517
Principal Investigator: Mark Farber, MD
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Charleston, South Carolina 29425
Principal Investigator: Ravi Veeraswamy
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Charleston, SC
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2525 Desales Avenue
Chattanooga, Tennessee 37403
Principal Investigator: Mark W Fugate, MD
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Concord, 2139
Principal Investigator: Anthony Freeman
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Concord,
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Mitchell Cox, MD
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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Flint, Michigan 98507
Principal Investigator: Nitin Malhotra, MD
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Honolulu, HI
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Little Rock, Arkansas 72205
Principal Investigator: Mohammed Moursi, MD
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Little Rock, AR
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Loma Linda, California 92357
Principal Investigator: Christian Bianchi, MD
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Loma Linda, CA
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Memphis, Tennessee 38120
Principal Investigator: H. Edward Garrett, MD
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Michigan Center, MI
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2500 Grant Rd
Mountain View, California 94040
(650) 940-7000
Principal Investigator: James Joye, DO
El Camino Hospital El Camino Hospital is a nonprofit organization with hospital campuses in Mountain...
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Mountain View, CA
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2300 Patterson Street
Nashville, Tennessee 37203
Principal Investigator: Adam Richter
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Nashville, TN
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Principal Investigator: Kristine Orion, MD
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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550 1st Ave
New York, New York 10016
(212) 263-7300
New York University Langone Medical Center NYU NYU Langone Medical Center, a world-class, patient-centered, integrated,...
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New York, NY
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New York, New York 11219
Principal Investigator: Robert Rhee
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New York, New York 10029
Principal Investigator: Vouyouka Ageliki, MD
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Norfolk, Virginia 23507
Principal Investigator: Jean Panneton, MD
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Norfolk, VA
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Principal Investigator: David Varnagy, MD
Florida Hospital Florida Hospital is one of the country
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Peoria, Illinois 61614
Principal Investigator: Dale Mueller, MD
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1910 East Thomas Road
Phoenix, Arizona 85006
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Queensbury, New York 12804
Principal Investigator: Manish Mehta
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Royal Oak, Michigan 48073
Principal Investigator: Paul Bove, MD
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Royal Oak, MI
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660 South Euclid Avenue
Saint Louis, Missouri 63110
Principal Investigator: Jeffery Jim, MD, MS
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Seattle, Washington 98104
Principal Investigator: Benjaimn Starnes, MD
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9600 Gross Point Road
Skokie, Illinois 60077
Principal Investigator: NavYash Gupta, MD
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Skokie, IL
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327 W Calhoun Ave
Springfield, Illinois 62702
(217) 545-0223
Southern Illinois University From its humble beginnings as the state's second teachers college - founded...
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Springfield, IL
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101 Nicolls Rd
Stony Brook, New York 11794
(631) 444-4000
Principal Investigator: Apostolos Tassiopoulos, MD
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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Stony Brook, NY
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Temple, Texas 76508
Principal Investigator: William Bohannon, MD
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Temple, TX
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Torrance, California 90502
Principal Investigator: Carlos Donayre, MD
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Torrance, California 90502
Principal Investigator: Carlos Donayre
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Washington, District of Columbia 20007
Principal Investigator: Edward Woo, MD
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Washington,
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West Columbia, South Carolina 29169
Principal Investigator: William M Moore, MD
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Wormleysburg, Pennsylvania 17043
Principal Investigator: David Loran, MD
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