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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P200045 S002/ PAS003 |
| Date Original Protocol Accepted |
08/04/2023
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| Date Current Protocol Accepted |
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| Study Name |
Registry Data Collection for Dissection
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| Device Name |
RelayPro Thoracic Stent-Graft System
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| General Study Protocol Parameters |
| Study Design |
Active Surveillance
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| Data Source |
Sponsor Registry
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
To collect real world, post-approval safety, performance, health economics and patient reported outcomes on patients treated with the RelayPro Thoracic Stent Graft System when used to repair Type B dissections in the descending thoracic aorta. This is a multi-center, prospective observational registry enrolling new patients
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| Study Population |
Patients requiring urgent or elective endovascular treatment of thoracic aortic acute and chronic dissections with the RelayPro Thoracic Stent-Graft System. There is no comparison group for the registry study.
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| Sample Size |
Number of subjects: A minimum of 60 patients with acute dissections and 60 patients with chronic dissections with a minimum of 50% of each indication from the US.
Assumptions for sample size estimation: A sample size of 120 provides 80% power (a =0.05) to distinguish an event that occurs with an incidence of 2% or greater from 0. That is, the 95% CI does not include 0.
Number of sites: 80
Sites location: US and OUS
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| Key Study Endpoints |
Technical success, defined as:
Successful delivery of the device through the vasculature (i.e. ability to deliver the implant to the intended location without the need for unanticipated corrective intervention related to delivery)
• Deployment of the endovascular stent-graft in the planned location with coverage of the target lesion (or entry tear in the case of dissection);
• Absence of unplanned coverage or aortic branch vessels;
• Patency of the endovascular stent-graft, absence of device deformations (e.g. kinks, stent eversion, maldeployment, misaligned deployment) requiring unplanned placement of an additional device within the endovascular stentgraft, and;
• Successful withdrawal (i.e. successful withdrawal of the delivery system, without the need for unanticipated corrective intervention related to withdrawal)
• Absence of Type Ia, Type Ib, Type IIIa and IIIb endoleak that extends beyond 30 days by confirmatory imaging (CTA, magnetic resonance angiography [MRA], or duplex ultrasound)
Clinical success, defined as the absence of:
• Target lesion related mortality
• Type Ia, Ib, IIIa and IIIb endoleak
• Graft infection
• Stent patency <50%
• Target lesion aortic rupture
• Conversion to open repair
• Arrest of the original pathological process (e.g., total aortic diameter expansion >5 mm in the aorta that has a study endograft, embolization from penetrating ulcer, extension of dissection, false lumen perfusion) or a new aortic pathology as a result of the intervention (e.g., pseudoaneurysm, dissection, intramural hematoma, unintentional adverse dissection septum rupture, stent-graft induced aortic wall injury, new aortobronchial/tracheal or aortoenteric fistula formation)
Additional endpoints:
• All-cause mortality
• Safety (MAEs, all related adverse events)
• Target lesion reintervention, all secondary interventions
• Device performance based on imaging assessments of all morphological variables (aortic remodeling, all endoleaks, any loss of patency, stent-graft migration, device integrity, etc.)
Patient outcome measures:
• Post-operative return to normal activities – employment, household activities, social life and hobbies (return to normal activities will be recorded at one year visit only)
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| Follow-up Visits and Length of Follow-up |
30 days, 6 months, 1 year and annually thereafter through five years
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