Blunt Thoracic Aortic Injury
Conditions
Keywords
Thoracic Aneurysm, Thoracic Transection, Endovascular Aortic Repair
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.
Interventions
All subjects will be implanted with this device
Sponsors
Medtronic
Medtronic Cardiovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause Mortality Within 30-days of the Index Procedure | 30 days |
Countries
Canada, United States
Participant flow
Recruitment details
A total of 25 investigational sites were activated and allowed to enroll in the RESCUE study in the US and Canada. A total of 50 subjects were enrolled at 20 of the 25 activated investigational sites, with the first enrollment on April 14, 2010 and the final enrollment on January 17, 2012.
Pre-assignment details
All 50 subjects enrolled were implanted with the device (Valiant Thoracic Stent Graft with the Captivia Delivery System ).
Participants by arm
| Arm | Count |
|---|---|
| Valiant Thoracic Stent Graft With the Captivia Delivery System | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Valiant Thoracic Stent Graft With the Captivia Delivery System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants |
| Age, Continuous | 40.7 years STANDARD_DEVIATION 17.4 |
| Region of Enrollment Canada | 2 participants |
| Region of Enrollment United States | 48 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 8 / 50 |
Outcome results
Primary
All-cause Mortality Within 30-days of the Index Procedure
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valiant Thoracic Stent Graft With the Captivia Delivery System | All-cause Mortality Within 30-days of the Index Procedure | 4 participants |