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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
University of California, Irvine
Irvine, California, United States
Stanford Medicine
Stanford, California, United States
Mortality post-procedure
All-cause mortality at 30 days post-procedure
Time frame: 30 days
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.
Time frame: During Implantation
Loss of stent-graft patency
Loss of stent-graft patency through 5 years
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Yale School of Medicine
New Haven, Connecticut, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
Indiana University Health
Indianapolis, Indiana, United States
University of Iowa Hospital and Clinic
Iowa City, Iowa, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center / Harvard Medical School
Boston, Massachusetts, United States
St. Louis University
St Louis, Missouri, United States
Atrium Health
Charlotte, North Carolina, United States
...and 6 more locations
Time frame: 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
Time frame: 1 month, 6 months, 12 months, and annually through 5 years
Aortic expansion
Aortic expansion (\> 5mm) compared to the first post-procedural CT
Time frame: 1 month, 6 months, 12 months, and annually through 5 years
Endograft infection
Infection of stent-graft
Time frame: 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
Time frame: 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
Time frame: 1 month, 6 months, 12 months, and annually through 5 years
Major adverse events
death, stroke, paralysis formation, or aortic expansion
Time frame: 1 month, 6 months, 12 months, and annually through 5 years
Aortic-related death
formation, or aortic expansion
Time frame: 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
Time frame: 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.
Time frame: 1 month, 6 months, 12 months, and annually through 5 years