Study to Determine if the Valiant Stent Graft is Safe and Effective in Treating Patients Who Have a Blunt Thoracic Aortic Injury
NCT ID: NCT01092767
Last Updated: 2021-10-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2010-04-30
2017-05-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Valiant Thoracic Stent Graft with the Captivia Delivery System
Valiant Thoracic Stent Graft with the Captivia Delivery System
Valiant Thoracic Stent Graft with the Captivia Delivery System
All subjects will be implanted with this device
Interventions
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Valiant Thoracic Stent Graft with the Captivia Delivery System
All subjects will be implanted with this device
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Medtronic Cardiovascular
INDUSTRY
Responsible Party
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Principal Investigators
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Rodney White, MD, FACS
Role: PRINCIPAL_INVESTIGATOR
Harbor UCLA
Locations
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University of Alabama
Birmingham, Alabama, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Harbor UCLA
Torrance, California, United States
Denver Health
Denver, Colorado, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
University of Florida Shands Hospital
Gainesville, Florida, United States
University of Miami Jackson Memorial
Miami, Florida, United States
Bayfront Medical Center
St. Petersburg, Florida, United States
Maine Medical Center
Portland, Maine, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Cooper Health
Camden, New Jersey, United States
Vascular Research Institute
Morristown, New Jersey, United States
Duke University Medical Center
Durham, North Carolina, United States
Toledo Hospital / Jobst Vascular Center
Toledo, Ohio, United States
UT Southwestern
Dallas, Texas, United States
Memorial Hermann Heart and Vascular Institute
Houston, Texas, United States
Brooke Army Medical Center
San Antonio, Texas, United States
Scott and White Memorial
Temple, Texas, United States
University Of Virginia
Charlottesville, Virginia, United States
Sentara Norfolk General Vascular & Transplant Specialists
Norfolk, Virginia, United States
Medical College of Wisconsin Froedtert Hospital
Milwaukee, Wisconsin, United States
London Health Sciences Center
London, Ontario, Canada
Laval Hospital
Québec, , Canada
Countries
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References
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Khoynezhad A, Donayre CE, Azizzadeh A, White R; RESCUE investigators. One-year results of thoracic endovascular aortic repair for blunt thoracic aortic injury (RESCUE trial). J Thorac Cardiovasc Surg. 2015 Jan;149(1):155-61.e4. doi: 10.1016/j.jtcvs.2014.09.026. Epub 2014 Sep 19.
Khoynezhad A, Azizzadeh A, Donayre CE, Matsumoto A, Velazquez O, White R; RESCUE investigators. Results of a multicenter, prospective trial of thoracic endovascular aortic repair for blunt thoracic aortic injury (RESCUE trial). J Vasc Surg. 2013 Apr;57(4):899-905.e1. doi: 10.1016/j.jvs.2012.10.099. Epub 2013 Feb 4.
Other Identifiers
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Investigational Plan #117
Identifier Type: -
Identifier Source: org_study_id