An interventional study of RelayPro in Aortic Aneurysm, Thoracic and Penetrating Ulcer, sponsored by Bolton Medical. Active, not recruiting at 35 sites in 2 countries. 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
Investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms (TAA) and penetrating atherosclerotic ulcers (PAU) of the descending thoracic aorta.
The objective of this study is to investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms and penetrating atherosclerotic ulcers of the descending thoracic aorta.
131 studies on the registry are indexed under Aortic Aneurysm, Thoracic; 33 are open to participants now.
This study's planned enrollment of 110 is above the median of 50 across 62 interventional studies indexed under Aortic Aneurysm, Thoracic.
Browse Aortic Aneurysm, Thoracic studies →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.
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.
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.
Endovascular treatment with the investigational device.
Device: RelayPro
Endovascular treatment with investigational device.
Rate of Major Adverse Events (MAEs)
Primary safety endpoint is a composite of the following MAEs occurring through 30 days: * Death * Stroke (excluding transient ischemic attack) * Paralysis (excludes paraparesis)
Time frame: 30 days
Technical success
Primary effectiveness rate as measured by the technical success through 24 hours, defined as: * Successful delivery of the device through the vasculature; * Successful deployment of the device at the intended location; Absence of Type I or III endoleaks; Patent stent-graft without significant stenosis.
Time frame: 24 hours
Stent graft patency
Primary effectiveness as measured by the rate of stent-graft patency through 12 months.
Time frame: 12 months
Aneurysm rupture
Primary effectiveness as measured by the absence of aneurysm rupture through 12 months.
Time frame: 12 months
Absence of Type I and III endoleak through 12 months;
Primary effectiveness as measured by the absence of Type I and III endoleak through 12 months.
Time frame: 12 months
Absence of stent fractures in the attachment zone through 12 months
Primary effectiveness as measured by the absence of stent fractures in the attachment zone through 12 months.
Time frame: 12 months
Absence of open or endovascular secondary interventions
Primary effectiveness as measured by the absence of open or endovascular secondary interventions related to the device or treated pathology through 12 months.
Time frame: 12 months
Absence of aneurysm expansion (> 5 mm diameter increase)
Primary effectiveness as measured by the absence of aneurysm expansion (\> 5 mm diameter increase) through 12 months, compared to the first post-procedural computed tomographic (CT) imaging study.
Time frame: 12 months
Absence of stent-graft migration
Primary effectiveness as measured by the absence of stent-graft migration (\> 10 mm) through 12 months, compared to the first post-procedural CT.
Time frame: 12 months
Loss of stent-graft patency
Loss of stent-graft patency will be assessed with CT scans, or MRIs for subjects unable to tolerate contrast media.
Time frame: 1 month and 6 months
Rate of aneurysm rupture
The rate of aneurysm rupture through 1 month and 6 months will be assessed by review of CT or MRI imaging, in addition to site reported adverse events.
Time frame: 1 month and 6 months
Rate of endoleaks of all types
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 will be assessed by CT scans or MRIs for subjects unable to tolerate contrast media.
Time frame: 1 month, 6 months and 12 months
Rate of 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 and 6 months
Incidence of open or endovascular secondary interventions
Secondary effectiveness will be measured by the incidence of open or endovascular secondary interventions related to the device or treated pathology (ie, interventions to treat malperfusion, rupture, aneurysm formation, or aortic expansion).
Time frame: 1 month and 6 months
Rate of aneurysm expansion
The rate of aneurysm expansion (\> 5 mm diameter increase) assessed by comparison of follow-up imaging to the first post-procedural CT
Time frame: 1 month and 6 months
Rate of stent-graft migration
The rate of stent-graft migration (\> 10 mm) assessed by comparison of follow-up imaging to the first post-procedural CT.
Time frame: 1 month and 6 months
Individual outcomes of composite MAEs
Secondary effectiveness as measured by the individual outcomes of the composite safety endpoints (death, stroke, paralysis), as well as myocardial infarction (MI), renal failure, respiratory failure, bowel ischemia, and procedural blood loss \>1,000 cc.
Time frame: 6 months and 12 months
Rate of vascular access complications
Secondary effectiveness as measured by the rate of vascular access complications reported during the Treatment visit (stent-graft implant). 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
Duration of implant procedure
Duration of the initial implant procedure captured as the number of minutes from introduction of device to removal of delivery system.
Time frame: Treatment Visit
Number of blood transfusions
Number of transfusions (units) required from the time of implant through hospital discharge.
Time frame: Treatment Visit through Discharge Visit
Duration of hospitalization
Length of hospital stay defined as number of days subject was hospitalized for the initial implant procedure.
Time frame: Treatment Visit through Discharge Visit
Time in Intensive Care Unit (ICU)
Duration of time in hours that subject was admitted to the Intensive Care Unit (ICU) following the implant procedure.
Time frame: Treatment Visit through Discharge Visit
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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