Clinical Study of the Treovance Stent-Graft for Patients With Abdominal Aortic Aneurysms



Status:Active, not recruiting
Conditions:Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 85
Updated:12/22/2017
Start Date:November 2013
End Date:June 2021

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A Phase II Clinical Study of the Safety and Performance of the Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms

The purpose of this clinical trial is to assess and evaluate the safety and efficacy of the
Treovance Stent-Graft with Navitel Delivery System in subjects with Abdominal Aortic
Aneurysms (AAA).

This is a phase II, multi-center, non-blinded, non-randomized study of treatment with the
Treovance Stent-Graft in subjects with abdominal aortic aneurysms. The study will include 150
subjects treated with the Treovance Stent-Graft at a maximum of 30 investigational sites.
There will be no prospective control group. Subjects diagnosed with infrarenal abdominal
aortic aneurysms enrolled in the trial will be treated with the Treovance Stent-Graft with
Navitel Delivery System. Pre-procedure baseline data will be gathered, as well as
post-procedure assessments prior to hospital discharge and 30 days, 6 months, and 12 months
post-implantation. In addition, annual follow-up visits out to 5 years will be conducted.

The primary goal of this study is to gather safety and effectiveness data on the Treovance
device. A maximum of 150 endovascular subjects will be required to fulfill the U.S. Phase II
requirements. The data from this study will be submitted to the FDA and used to support
approval in the U.S.

There are two primary objectives, efficacy and safety of the Treovance Stent-Graft in
subjects with infrarenal aortic aneurysms:

- Primary Efficacy will be evaluated by successful aneurysm treatment 12 months
post-implant

- Primary Safety will be assessed by composite major adverse event (MAE) rate at 30-days

Secondary objectives involve assessment of major device-related events and major morbidity.

Inclusion Criteria:

- Subject must be diagnosed with an infrarenal abdominal aortic aneurysm (AAA), with or
without iliac artery involvement

- Subject must have an infrarenal AAA that is > 4.5 cm in diameter for males, or > 4.0
cm in diameter for females, or has increased in diameter by 0.5 cm in the last 6
months

Exclusion Criteria:

- Subject has a dissection in abdominal aorta, ruptured aneurysm, or symptomatic
aneurysm (as determined by treating physician)

- Subject has had a prior AAA repair (endovascular or surgical)

- Subject is participating in another research study, has received investigational study
drug within 30 days of planned procedure, or has received an investigational device
within one year of planned procedure
We found this trial at
32
sites
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Ross Milner, MD
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: William Jordan, MD
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Mark Conrad, MD
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Boston, MA
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Iowa City, Iowa 52242
Principal Investigator: Melhem Sharafuddin, MD
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Iowa City, IA
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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New York, NY
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Principal Investigator: Jeff Slaiby, MD
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Providence, RI
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Albany, New York 12208
Principal Investigator: Manish Mehta, MD
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Asheville, North Carolina 28801
Principal Investigator: John Henretta, MD
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Atlanta, Georgia 30342
Principal Investigator: Joseph Ricotta, MD
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Atlanta, GA
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Boca Raton, Florida 33486
Principal Investigator: W A Lee, MD
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Boston, Massachusetts 02111
Principal Investigator: Mark Iafrati, MD
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Buffalo, New York 14203
Principal Investigator: Maciej Dryjski, MD
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Charlotte, North Carolina 28203
Principal Investigator: Stephen Lalka, MD
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Michael Park, MD
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Mounir Haurani, MD
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Danbury, Connecticut 06810
Principal Investigator: Alan Dietzek, MD
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Grand Rapids, Michigan 49503
Principal Investigator: Christopher Chambers, MD
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Greenville, North Carolina 27834
Principal Investigator: Frank Parker, MD
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Norfolk, Virginia 23507
Principal Investigator: Jean Panneton, MD
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Pensacola, Florida 32204
Principal Investigator: Stuart Harlin, MD
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Benjamin Jackson, MD
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, Pennsylvania 19140
Principal Investigator: Grayson Wheatley, MD
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Phoenix, Arizona 85006
Principal Investigator: Venkatesh Ramaiah, MD
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Michael Singh, MD
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Rochester, Minnesota 55905
Principal Investigator: Randall De Martino, MD
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Rochester, New York 14618
Principal Investigator: Michael Stoner, MD
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Rockford, Illinois 61103
Principal Investigator: Paul Klazura, MD
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Sioux Falls, South Dakota 51108
Principal Investigator: Michael Bacharach, MD
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Sioux Falls, South Dakota 57117
Principal Investigator: Angelo Santos, MD
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Stony Brook, New York 11794
Principal Investigator: Apostolos Tassiopoulos, MD
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Worcester, Massachusetts 01655
Principal Investigator: Andres Schanzer, MD
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York, Pennsylvania 17315
Principal Investigator: Nancy Harthun, MD
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