Clinical trial NCT01092767: Study to Determine if the Valiant Stent Graft is Safe and Effective in Treating Patients Who Have a Blunt Thoracic Aortic Injury
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blunt Thoracic Aortic Injury
Keywords: Thoracic Aneurysm
Thoracic Transection
Endovascular Aortic Repair
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2010-03-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: All-cause Mortality Within 30-days of the Index Procedure
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Torrance
country: United States
facility: Harbor UCLA
state: California
city: Denver
country: United States
facility: Denver Health
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida Shands Hospital
state: Florida
city: Miami
country: United States
facility: University of Miami Jackson Memorial
state: Florida
city: Saint Petersburg
country: United States
facility: Bayfront Medical Center
state: Florida
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Camden
country: United States
facility: Cooper Health
state: New Jersey
city: Morristown
country: United States
facility: Vascular Research Institute
state: New Jersey
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Toledo
country: United States
facility: Toledo Hospital / Jobst Vascular Center
state: Ohio
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Heart and Vascular Institute
state: Texas
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Temple
country: United States
facility: Scott and White Memorial
state: Texas
city: Charlottesville
country: United States
facility: University Of Virginia
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Vascular & Transplant Specialists
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin Froedtert Hospital
state: Wisconsin
city: London
country: Canada
facility: London Health Sciences Center
state: Ontario
city: Quebec
country: Canada
facility: Laval Hospital
Study officials:
affiliation: Harbor UCLA
name: Rodney White, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.