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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)
This is a prospective, multicenter, non-blinded, non-randomized study of the RelayPro Thoracic Stent-Graft in subjects with traumatic injury of the DTA in subjects who are candidates for endovascular repair.The primary objective of the study is all-cause mortality at 30 days post procedure.
The secondary objectives of the trial will include descriptive analyses of procedural and post-procedural observations through 5 years of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relay Pro Thoracic Stent-Graft System | Experimental | The Relay Pro arm includes subjects who receive the device to treat traumatic injury of the descending thoracic aorta with the RelayPro Thoracic Stent-Graft System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relay Pro Thoracic Stent-Graft System | Device | RelayPro Thoracic Stent-Grafts are designed for the management of patients with aneurysms and penetrating ulcers within the descending thoracic aorta (DTA). The device is designed specifically for use in the thoracic aorta. |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality post-procedure | All-cause mortality at 30 days post-procedure | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Successful device delivery and deployment | Successful delivery and deployment of the device, including withdrawal of the delivery system, will be assessed with angiography during the index procedure at the Treatment Visit. | During Implantation |
| Loss of stent-graft patency |
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Inclusion Criteria:
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.
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ben Starnes, MD | University of Washington | Principal Investigator |
| Ravi Rajani, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine | Irvine | California | 92868 | United States | ||
| Stanford Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38677660 | Derived | Starnes BW, Rajani RR, Rossi P, Singh N, Benarroch-Gampel J, Cho JS, Nassiri N, Smeds MR, Kalapatapu V, Stern JR, Kabutey NK, Corvera J; RelayPro Investigators. Early survival benefit of a low-profile endograft in blunt traumatic aortic injury. J Vasc Surg. 2024 Sep;80(3):678-684.e1. doi: 10.1016/j.jvs.2024.04.051. Epub 2024 Apr 25. |
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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. All subjects enrolled, will be included in the patient population for the primary analysis. All subjects implanted with the RelayPro Thoracic Stent-Graft will be included in the patient population for the secondary analyses.
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Loss of stent-graft patency through 5 years |
| 1 month, 6 months, 12 months, and annually through 5 years |
| Aortic rupture | Aortic rupture will be assessed at each follow-up visit with CT scans, or MRIs for subjects unable to tolerate contrast media | 1 month, 6 months, 12 months, and annually through 5 years |
| Stent fractures in the attachment zone | Stent fractures in the attachment zone will be assessed at each follow-up visit with CT scans, or MRIs for subjects unable to tolerate contrast media | 1 month, 6 months, 12 months, and annually through 5 years |
| Endoleaks | Persistence of blood flow outside the lumen of the stent-graft but within the native aorta or adjacent vascular segment being treated by the stent-graft | 1 month, 6 months, 12 months, and annually through 5 years |
| Compression of stent-graft | Extra-luminal compression of the stent-graft will be assessed at each follow-up visit with xrays, CT scans, or MRIs for subjects unable to tolerate contrast media | 1 month, 6 months, 12 months, and annually through 5 years |
| Erosion and/or extrusion | Erosion and extrusion will be assessed at each follow-up visit with CT scans, or MRIs for subjects unable to tolerate contrast media | 1 month, 6 months, 12 months, and annually through 5 years |
| Aortic expansion | Aortic expansion (> 5mm) compared to the first post-procedural CT | 1 month, 6 months, 12 months, and annually through 5 years |
| Endograft infection | Infection of stent-graft | 1 month, 6 months, 12 months, and annually through 5 years |
| Incidence of open or endovascular secondary interventions | Incidence of open or endovascular secondary interventions to treat malperfusion, rupture, aneurysm formation, or aortic expansion | 1 month, 6 months, 12 months, and annually through 5 years |
| Migration | Stent migration (> 10 mm) compared to the first post-procedural CT; formation, or aortic expansion | 1 month, 6 months, 12 months, and annually through 5 years |
| Major adverse events | death, stroke, paralysis formation, or aortic expansion | 1 month, 6 months, 12 months, and annually through 5 years |
| Aortic-related death | formation, or aortic expansion | 1 month, 6 months, 12 months, and annually through 5 years |
| Vascular access complications | The Time Frame for reporting is during the Treatment Visit. Data should be captured upon conclusion of the Treatment Visit. Outcome measures include successful delivery and deployment of the device, as well as withdrawal of the delivery system | During the initial implant attempt |
| All-cause mortality | All causes where subject death is the result of a serious and device- or procedure related adverse effect. Unrelated and accidental deaths, for example a subject death due to injuries sustained from a gunshot wound, would not be included in the evaluation. | 1 month, 6 months, 12 months, and annually through 5 years |
| Stanford |
| California |
| 94305-5639 |
| United States |
| Yale School of Medicine | New Haven | Connecticut | 06510 | United States |
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States |
| Indiana University Health | Indianapolis | Indiana | 46202 | United States |
| University of Iowa Hospital and Clinic | Iowa City | Iowa | 52242 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Beth Israel Deaconess Medical Center / Harvard Medical School | Boston | Massachusetts | 02215 | United States |
| St. Louis University | St Louis | Missouri | 63110 | United States |
| Atrium Health | Charlotte | North Carolina | 28203 | United States |
| University Hospitals | Cleveland | Ohio | 44106 | United States |
| University of Pennsylvania Medical Center / Penn Presbyterian | Philadelphia | Pennsylvania | 19104 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| University of Washington | Seattle | Washington | 98105 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |