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

Purpose

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.

Condition	Intervention
Blunt Thoracic Aortic Injury	Device: Valiant Thoracic Stent Graft with the Captivia Delivery System

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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)

Resource links provided by NLM:

Genetics Home Reference related topics: familial thoracic aortic aneurysm and dissection

MedlinePlus related topics: Aneurysms

U.S. FDA Resources

Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:

All patients are alive [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	April 2010
Estimated Study Completion Date:	May 2017
Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Valiant Thoracic Stent Graft with the Captivia Delivery System	Device: Valiant Thoracic Stent Graft with the Captivia Delivery System All subjects will be implanted with this device

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Subject has a blunt thoracic aortic injury.

Exclusion Criteria:

Subject has received a previous stent or stent graft or previous surgical repair in the descending thoracic artery (DTA).
Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.
Subject has a known allergy or intolerance to the device components.
Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01092767

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Locations

United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Rodney White, M.D., F.A.C.S.
Torrance, California, United States, 90502
United States, Colorado
Denver Health
Denver, Colorado, United States, 80204
United States, Connecticut
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
United States, Florida
University of Florida Shands Hospital
Gainesville, Florida, United States, 32608
University of Miami Jackson Memorial
Miami, Florida, United States, 33136
Bayfront Medical Center
St. Petersberg, Florida, United States, 33709
United States, Maine
Main Medical Center
Falmouth, Maine, United States, 04105
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, New Jersey
Cooper Health
Camden, New Jersey, United States, 08103
Vascular Research Institute
Morristown, New Jersey, United States, 07960
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Toledo Hospital / Jobst Vascular Center
Toledo, Ohio, United States, 43606
United States, Texas
UT Southwestern
Dallas, Texas, United States, 75390
Memorial Hermann Heart and Vascular Institute
Houston, Texas, United States, 77030
Brooke Army Medical Center
San Antonio, Texas, United States, 78234
Scott and White Memorial
Temple, Texas, United States, 76508
United States, Virginia
University Of Virginia
Charlottesville, Virginia, United States, 22908
Sentara Norfolk General Vascular & Transplant Specialists
Norfolk, Virginia, United States, 23507
United States, Wisconsin
Medical College of Wisconsin Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226
Canada, Ontario
London Health Sciences Center
London, Ontario, Canada, N6A5W9
Canada
Laval Hospital
Quebec, Canada, QCG1V

Sponsors and Collaborators

Medtronic Endovascular

Medtronic

Investigators

Principal Investigator:

Rodney White, M.D., F.A.C.S.

Harbor UCLA

More Information

No publications provided

Responsible Party:	Medtronic Endovascular
ClinicalTrials.gov Identifier:	NCT01092767 History of Changes
Other Study ID Numbers:	Investigational Plan #117
Study First Received:	March 16, 2010
Last Updated:	January 25, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medtronic Endovascular:

Thoracic Aneurysm
Thoracic Transection
Endovascular Aortic Repair

ClinicalTrials.gov processed this record on May 22, 2013

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