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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Blunt Thoracic Aortic Injury

Intervention / Treatment
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* Device: Valiant Thoracic Stent Graft with the Captivia Delivery System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Valiant Thoracic Stent Graft with the Captivia Delivery System<br>Valiant Thoracic Stent Graft with the Captivia Delivery System | Device: Valiant Thoracic Stent Graft with the Captivia Delivery System<br>* All subjects will be implanted with this device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause Mortality Within 30-days of the Index Procedure |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracic Aneurysm, Thoracic Transection, Endovascular Aortic Repair