Study to Determine if the Valiant Stent Graft is Safe and Effective in Treating Patients Who Have a Blunt Thoracic Aortic Injury
RESCUE
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)
1 other identifier
interventional
50
2 countries
25
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2010
Longer than P75 for not_applicable
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2010
CompletedFirst Posted
Study publicly available on registry
March 25, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedResults Posted
Study results publicly available
March 28, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedOctober 29, 2021
October 1, 2021
2 years
March 16, 2010
February 13, 2014
October 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All-cause Mortality Within 30-days of the Index Procedure
30 days
Study Arms (1)
Valiant Thoracic Stent Graft with the Captivia Delivery System
EXPERIMENTALValiant Thoracic Stent Graft with the Captivia Delivery System
Interventions
All subjects will be implanted with this device
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic Cardiovascularlead
- Medtroniccollaborator
Study Sites (25)
University of Alabama
Birmingham, Alabama, 35294, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Harbor UCLA
Torrance, California, 90502, United States
Denver Health
Denver, Colorado, 80204, United States
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
University of Florida Shands Hospital
Gainesville, Florida, 32608, United States
University of Miami Jackson Memorial
Miami, Florida, 33136, United States
Bayfront Medical Center
St. Petersburg, Florida, 33709, United States
Maine Medical Center
Portland, Maine, 04105, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Cooper Health
Camden, New Jersey, 08103, United States
Vascular Research Institute
Morristown, New Jersey, 07960, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Toledo Hospital / Jobst Vascular Center
Toledo, Ohio, 43606, United States
UT Southwestern
Dallas, Texas, 75390, United States
Memorial Hermann Heart and Vascular Institute
Houston, Texas, 77030, United States
Brooke Army Medical Center
San Antonio, Texas, 78234, United States
Scott and White Memorial
Temple, Texas, 76508, United States
University Of Virginia
Charlottesville, Virginia, 22908, United States
Sentara Norfolk General Vascular & Transplant Specialists
Norfolk, Virginia, 23507, United States
Medical College of Wisconsin Froedtert Hospital
Milwaukee, Wisconsin, 53226, United States
London Health Sciences Center
London, Ontario, N6A5W9, Canada
Laval Hospital
Québec, QCG1V, Canada
Related Publications (2)
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.
PMID: 25439771DERIVEDKhoynezhad 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.
PMID: 23384495DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Laura Regan, MPH - Study Lead
- Organization
- Medtronic, Inc., Aortic and Peripheral Vascular
Study Officials
- PRINCIPAL INVESTIGATOR
Rodney White, MD, FACS
Harbor UCLA
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2010
First Posted
March 25, 2010
Study Start
April 1, 2010
Primary Completion
April 1, 2012
Study Completion
May 1, 2017
Last Updated
October 29, 2021
Results First Posted
March 28, 2014
Record last verified: 2021-10