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Home » Clinical Trials » Aneurysm

Clinical Trial Details

Overview

Research Study Summary

A clinical trial seeking patients for a research study for the treatment of Abdominal Aortic Aneurysm

Research Study Title

Aneurysm Treatment Using the HeliFX Aortic Securement System Global Registry

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.

To Learn more
Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Lead Sponsor

Aptus Endosystems

Duration

23 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 18 Years and up

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.

Site Locations (19)

Country State City Zip Facility and Contact
United States Alabama Birmingham 35294 University of Alabama

William D Jordan, Jr, MD
Principal Investigator
United States Arizona Phoenix 84006 Arizona Heart Institute

Ramaiah Venkatesh, MD
Principal Investigator
United States California Mountain View 94040 El Camino Hospital

James Joye, DO
Principal Investigator
United States California Torrance 90509 Harbor - UCLA

Carlos Donayre, MD
Principal Investigator
United States Florida Orlando 32751 Florida Hospital

David Varnagy, MD
Principal Investigator
United States Hawaii Honolulu 96819 Hawaii Permanente Medical Group

Peter Schneider, MD
Principal Investigator
United States Illinois Springfield 62702 Southern Illnois University School of Medicine

Kim J Hodgson, MD
Principal Investigator
United States Massachusetts Boston 02215 Beth Israel Deaconess-Harvard
Marc Sherhermon, MD

Marc Sherhermon, MD
Principal Investigator
United States Michigan Ann Arbor 48109-5867 University of Michigan

Guillermo A Escobar, MD
Principal Investigator
United States Michigan Flint 98507 Michigan Vascular Center

Nitin Malhotra, MD
Principal Investigator
United States Missouri St. Louis 63110 Washington University School of Medicine, Barnes Jewish West County Hospital

Jeffery Jim, MD, MS
Principal Investigator
United States New Hampshire Lebanon 03756 Dartmouth-Hitchcock Medical Center

Mark Fillinger, MD
Principal Investigator
United States New York Bronx 10467 Montefiore Medical Center

Evan C Lipsitz, MD
Principal Investigator
United States North Carolina Ashville 28806 Carolina Vascular-Mission Hospital
John Henretta, MD

John Henretta, MD
Principal Investigator
United States North Carolina Chapel Hill 27599 UNC

Mark Farber, MD
Principal Investigator
United States Ohio Cleveland 44195 Cleveland Clinic

Daniel Clair, MD
Principal Investigator
United States South Carolina West Columbia 29169 Lexington Medical Center

William M Moore, MD
Principal Investigator
United States Tennessee Nashville 37232 Vanderbilt University Medical Center

Thomas C Naslund, MD
Principal Investigator
United States Texas Temple 76508 Scott and White Medical Center

William Bohannon, MD
Principal Investigator

Contact

Esmeralda Sanjust
408.585.7328

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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NCT ID: NCT01534819

Date Last Changed: August 28, 2012

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