Study of the Relay Pro® Thoracic Stent-Graft in Subjects With Traumatic Injury of the Descending Thoracic Aorta

Exclusion Criteria

• •Significant stenosis, calcification, thrombus, or tortuosity of intended fixation sites that would compromise fixation or seal of the device.
• •Planned coverage of left carotid or celiac arteries; or anatomic variants that may compromise circulation to the carotid, vertebral, or innominate arteries after device placement, and are not amenable to subclavian revascularization
• •Prior endovascular or surgical repair in the DTA. The device may not be placed within any prior endovascular or surgical graft.
• •Concomitant aneurysm/disease of the ascending aorta, aortic arch, or abdominal, aorta requiring repair.
• •Prior abdominal aortic aneurysm repair (endovascular or surgical) that was performed less than 6 months prior to the planned stent implant procedure.
• •Untreatable allergy or sensitivity to contrast media or device components.
• •Known or suspected connective tissue disorder.
• •Blood coagulation disorder or bleeding diathesis for which the treatment cannot be suspended for one week pre- and/or post-repair.
• •Coronary artery disease with unstable angina.
• •Severe congestive heart failure (New York Heart Association functional class IV).
• •Stroke and/or Myocardial Infarction within 3 months of the planned treatment date.
• •Pulmonary disease requiring the routine (daily or nightly) need for oxygen therapy outside the hospital setting.
• •Acute renal failure or chronic renal insufficiency, and not receiving dialysis.
• •Hemodynamically unstable.
• •Active systemic infection and/or mycotic aneurysms.
• •Morbid obesity or other condition that may compromise or prevent the necessary imaging requirements.
• •Injury Severity Score of 75.
• •Less than two-year life expectancy.
• •Current or planned participation in an investigational drug or device study that has not completed primary endpoint evaluation.
• •Currently pregnant or planning to become pregnant during the course of the study.
• •Medical, social, or psychological issues that Investigator believes may interfere with treatment or follow-up.