Skip Navigation

Advertise|Press|Contact|FAQ|CWConnect

Bookmark/Print/Share

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 Heli-FX Aortic Securement System Global Registry

Purpose

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 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

47 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 Heli-FX EndoAnchor 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 Heli-FX 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 a Heli-FX 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 Heli-FX penetration of the aortic wall

  • Use where, for whatever reason, each Heli-FX is not anticipated to adequately penetrate into the aortic wall.

Site Locations (56)

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 Arkansas Little Rock 72205 Central Arkansas Veterans Health System

Mohammed Moursi, MD
Principal Investigator
United States California Loma Linda 92357 Loma Linda VA Medical Center

Christian Bianchi, 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 Connecticut New Haven 06510 Yale University School of Medicine

Jeffrey Indes, MD
Principal Investigator
United States District of Columbia Washington 20007 MedStar Georgetown University Hospital Vascular Surgery Dept.

Edward Woo, MD
Principal Investigator
United States Florida Miami 33176 Baptist Cardiac & Vascular Institute

Barry Katzen, MD
Principal Investigator
United States Florida Orlando 32751 Florida Hospital

David Varnagy, MD
Principal Investigator
United States Florida Tampa 33606 University of South Florida

Martin Back, MD
Principal Investigator
United States Hawaii Honolulu 96819 Hawaii Permanente Medical Group

Peter Schneider, MD
Principal Investigator
United States Illinois Peoria 61614 HeartCare Midwest

Dale Mueller, MD
Principal Investigator
United States Illinois Skokie 60077 Department of Surgery NorthShore University HealthSystem

NavYash Gupta, MD
Principal Investigator
United States Maryland Baltimore 21201 Division of Cardiac Surgery UMD School of Medicine

Robert Crawford, MD
Principal Investigator
United States Maryland Baltimore 21401 Johns Hopkins Bayview Medical Center

Mahmoud Malas, MD
Principal Investigator
United States Massachusetts Boston 02215 Beth Israel Deaconess-Harvard
Marc Sherhermon, MD

Marc Sherhermon, MD
Principal Investigator
United States Michigan Flint 98507 Michigan Vascular Center

Nitin Malhotra, MD
Principal Investigator
United States Michigan Royal Oak 48703 William Beaumont Hospital

Paul Bove, 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 Albany 12208 Albany Medical Center

Manish Mehta, MD
Principal Investigator
United States New York Bronx 10467 Montefiore Medical Center

Evan C Lipsitz, MD
Principal Investigator
United States New York New York City 10029 Department of Surgery Mount Sinai Medical Center

Sharif Ellozy, MD
Principal Investigator
United States New York New York City 10016 New York University

Mark Adelman, MD
Principal Investigator
United States New York Stony Brook 11794 Stony Brook University Medical Center

Apostolos Tassiopoulos, 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 North Carolina Charlotte 28203 Carolinas Health Care Div. of Vascular and Endovascular Surgery

Frank Arko, MD
Principal Investigator
United States North Carolina Durham 27710 Duke University Medical Center

Mitchell Cox, MD
Principal Investigator
United States Ohio Cleveland 44195 Cleveland Clinic

Daniel Clair, MD
Principal Investigator
United States Pennsylvania Wormleysburg 17043 Pinnacle Health

Brijeshwar Maini, MD
Principal Investigator
United States South Carolina West Columbia 29169 Lexington Medical Center

William M Moore, MD
Principal Investigator
United States Tennessee Memphis 38120 Cardiovascular Surgery Clinic, PLLC

H. Edward Garrett, 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
United States Virginia Norfolk 23507 Norfolk Sentara Hospital

Marc Glickman, MD
Principal Investigator
United States Washington Seattle 98104 Harborview Medical Center, University of Washington

Benjaimn Starnes, MD
Principal Investigator
France Creteil Henri Mondor Hospital

Jean-Pierre Becquemin, MD
Principal Investigator
Germany Berlin Deutsches Herzzentrum

Burkhart Zipfel, MD
Principal Investigator
Germany Frankfurt Cardiovascular Center Frankfurt

Horst Sievert, MD
Principal Investigator
Germany Heidelberg University Hospital Heidelberg

Dittmar Bockler, MD
Principal Investigator
Germany Leipzig Park Hospital Leipzig

Dierk Scheinert, MD
Principal Investigator

Andrej Schmidt, MD
Principal Investigator
Germany Lingen St. Bonifatius Hospital

Joerg Tessarek, MD
Principal Investigator
Germany Ludwigsburg Klinikum Ludwigsburg

Johannes Gahlen, MD
Principal Investigator
Germany Munich Technical University of Munich

Hans-Henning Eckstein, MD
Principal Investigator
Germany Munster St. Franzsikus-Hospital GmbH

Giovanni Torsello, MD
Principal Investigator
Germany Nuremberg Klinikum Nuremberg

Eric Verhoeven, MD
Principal Investigator
Italy Siena University of Siena

Carlo Setacci, MD
Principal Investigator
Netherlands Arnhem Rijnstate Hospital

Michael Reijnen, MD
Principal Investigator
Netherlands Nieuwegein St. Antonius Hospital

Jean-Paul de Vries, MD
Principal Investigator
Netherlands Rotterdam Maasstad Hospital Rotterdam

Bram Fioole, MD
Principal Investigator
Netherlands Utrecht UMC Utrecht

Joost van Herwaarden, MD
Principal Investigator

F.L. Moll, MD
Principal Investigator
Spain Barcelona Thorax Institute Hospital Clinic

Vincent Riambau, MD
Principal Investigator
Sweden Malmo Malmo University Hospital

Timothy Resch, MD
Principal Investigator
United Kingdom London Imperial College Healthcare NHS Trust

Nick Cheshire, MD
Principal Investigator

Colin Bicknell, MD
Principal Investigator

Contact

Irene Kuhn
212.266.0126
E-mail:

NCT ID: NCT01534819

Date Last Changed: November 17, 2014

DISCLAIMER: This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials. Some study summaries have been edited for clarity purposes to make them easier to understand. View more study details here.