A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects With Traumatic Injury of the Descending Thoracic Aorta
The purpose of this study is to investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with traumatic injury of the descending thoracic aorta (DTA)
• Age greater than 18 years
• Subject must have a traumatic injury of the descending thoracic aorta that occurred no more than 30 days prior to the planned stent implant procedure
• Proximal and distal landing zones with diameter between 19 mm and 42 mm.
• Subject must have a proximal attachment zone distal to the left common carotid and a distal attachment zone proximal to the origin of the celiac artery.
• The length of the attachment zones will depend on the intended stent graft diameter.
• The proximal attachment zone should be: i. 15 mm for 22 - 28 mm grafts with bare stent (20 mm for RelayPro grafts with non-bare stent). ii. 20 mm for 30 - 46 mm grafts with bare stent (25 mm for RelayPro grafts with non-bare stent).
• The distal attachment zone should be 20 mm for all Relay Pro grafts.
• Coverage of the left subclavian artery is permitted. Revascularization of the left subclavian artery may be considered in all cases by the treating physician and, especially, in anatomies where revascularization is determined to be clinically necessary
• Proximal and distal attachment zones containing a straight segment (non-tapered, non-reverse tapered, defined by <10% diameter change) with lengths equal to or greater than the required attachment length for the intended device.
• Adequate iliac or femoral artery access for introduction of the RelayPro delivery system. Alternative methods to gain proper access may be utilized (e.g., iliac conduit).
• Subject willing to comply with the follow-up evaluation schedule.
• Subject (or Legally Authorized Representative, LAR) agrees to sign an Informed Consent Form prior to treatment