Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT01092767
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01092767
Study Brief:
Protocol Section:
NCT01092767