An interventional study of Relay Pro Thoracic Stent-Graft System in Other Specified Injury of Thoracic Aorta, sponsored by Bolton Medical. Active, not recruiting at 16 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-31.
Sponsored by Bolton Medical (part of Terumo Corporation) · Not applicable, Interventional, and Treatment
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.
Bolton Medical is the lead sponsor of 14 studies on the registry; none are open to participants now.
First submitted before Bolton Medical became part of Terumo Corporation.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The length of the attachment zones will depend on the intended stent graft diameter.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Device: Relay Pro Thoracic Stent-Graft System
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.
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
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
Plan to share: No
This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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