Study to Determine if the Valiant Stent Graft is Safe and Effective in Treating Patients Who Have a Blunt Thoracic Aortic Injury



Status:Completed
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:2/9/2018
Start Date:April 2010
End Date:May 2017

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Evaluation of the Clinical Performance of the Valiant Thoracic Stent Graft With the Captivia Delivery System for the Endovascular Treatment of Blunt Thoracic Aortic Injuries (RESCUE)

The purpose of this study is to determine if the Valiant stent graft is safe and effective in
treating patients who have a blunt thoracic aortic injury (BTAI). BTAI is when the aorta has
been injured due to traumatic force to the chest area. It is commonly caused by motor vehicle
accidents. In most cases it is life threatening and the standard treatment is surgery. Many
times when a person has a BTAI they also have other injuries that can affect the results of
the surgery.

Since stent grafting has been an effective way to treat other aortic conditions such as
aneurysms (bulge in aorta wall), it is believed that the Valiant stent graft would be
effective in treating BTAI. A stent graft is a woven polyester tube (graft) supported by a
metal frame of strong but flexible nitinol (type of metal) springs (stent) that is placed in
the aorta to help seal the injury and keep it from bleeding.


Inclusion Criteria

- Subject had a blunt thoracic aortic injury which:

- was confirmed, at a minimum, by diagnostic contrast-enhanced computerized tomography
angiogram (CTA) and/or contrast-enhanced magnetic resonance angiogram (MRA)

- occurred no more than 30 days prior to the stent implant procedure

- Subject was ≥ 18 years of age

- Subject or subject's legally authorized representative signed an IRB approved informed
consent

- Subject was hemodynamically stable

- Subject's anatomy met all of the following anatomical criteria:

- Aortic diameter (adventitia to adventitia) of the proximal and distal landing zones
between 18 mm and 44 mm

- Subject had patent iliac or femoral arteries or could tolerate an iliac conduit that
allowed endovascular access to the injury site with the delivery system of the
appropriate sized device

- The centerline distance from the distal margin of left common carotid artery (LCC) to
the injury was ≥ 20 mm

Exclusion Criteria

- Planned placement of the COVERED portion of the stent graft over the celiac axis or
the LCC, or in cases of bovine anatomy, innominate artery

- Subject had systemic infection

- Subject was pregnant

- Subject had received a previous stent or stent graft or previous surgical repair in
the DTA

- Subject had a history of bleeding diathesis, coagulopathy, or refuses blood
transfusion

- Subject was participating in an investigational drug or device clinical trial which
would interfere with the endpoints and/or follow-ups of this study

- Subject had a known allergy or intolerance to the device components

- Subject had a known hypersensitivity or contraindication to anticoagulants or contrast
media, which was not amenable to pre-treatment

- Subject was in extremis, defined as subject that had non-survivable injury/condition

- Subject had a Cerebral Vascular Accident (CVA) within two (2) months prior to implant
procedure
We found this trial at
24
sites
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
1444
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Boston, MA
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
1168
mi
from
Los Angeles, CA
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22 Bramhall St
Portland, Maine 04102
(207) 662-0111
Maine Medical Center One of the country's consistently highest rated hospitals is right in your...
1492
mi
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Portland, ME
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
808
mi
from
Ann Arbor, MI
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Birmingham, Alabama 35294
683
mi
from
Birmingham, AL
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Camden, New Jersey
1227
mi
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Camden, NJ
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Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
1049
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Charlottesville, VA
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Dallas, Texas 75390
349
mi
from
Dallas, TX
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Denver, Colorado 80204
411
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Denver, CO
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
1052
mi
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Durham, NC
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Gainesville, Florida 32608
1048
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Gainesville, FL
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572
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Houston, TX
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942
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London,
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1321
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Miami, FL
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630
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Milwaukee, WI
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Morristown, New Jersey 07960
1262
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Morristown, NJ
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
1344
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New Haven, CT
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1181
mi
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Norfolk, VA
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Royal Oak, Michigan 48073
838
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Royal Oak, MI
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701 6th Street South
Saint Petersburg, Florida 33701
1117
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Saint Petersburg, FL
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San Antonio, Texas 78234
574
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San Antonio, TX
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Temple, Texas 76508
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Temple, TX
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801
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Toledo, OH
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Torrance, California 90502
1176
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Torrance, CA
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