Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Medtronic Cardiovascular
With
Medtronic
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | Study to Determine if the Valiant Stent Graft is Safe and Effective in Treating Patients Who Have a Blunt Thoracic Aortic Injury
