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|
| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
P200045 / PAS002 |
| Date Original Protocol Accepted |
11/16/2021
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| Date Current Protocol Accepted |
|
| Study Name |
RelayPro Post-Approval Surveillance Study
|
| Device Name |
RelayPro Thoracic Stent-Graft System
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Transit. Adolescent A (distinctively) : 18-21 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
To collect real world, post-approval safety, performance, patient reported outcomes and health economic data on patients treated with Terumo Aortic endovascular stent-grafts in standard clinical practice.
This is a multi-center, open label, prospective observational registry enrolling new patients to obtain safety and performance data for the RelayPro Thoracic Stent-Graft System.
|
| Study Population |
Patients requiring urgent or elective endovascular treatment of thoracic aortic aneurysm, pseudoaneurysm, dissection, penetrating aortic ulcer or intramural hematoma treated with the RelayPro Thoracic Stent-Graft System
There is no comparison group for the registry study
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| Sample Size |
A minimum of 177 aneurysm subjects treated with the RelayPro Thoracic Stent-Graft System will be enrolled. Of these a minimum of 88 patients will be enrolled in the U.S.
A sample size of 161 subjects provides 80% power (a =0.05) to distinguish any event that occurs at 1% or greater from 0. To allow for 10% attrition at 1 year, a minimum of 177 patients will be enrolled and analyzed.
Up to 80 global sites, including up to 40 US sites will be enrolled.
|
| Key Study Endpoints |
Primary Outcome
The primary outcome is Aortic-related mortality, defined as any death due to aortic rupture, malperfusion or aortic dissection.
Secondary Outcomes
All-cause mortality
Technical Success
Clinical Success
Serious Adverse Events
Major Adverse Events
Patient Outcomes (Post-operative return to normal activities – employment, household activities, social life
and hobbies)
Procedure related health Economics (e.g., total procedure time, blood loss, volume of contrast used etc.)
Summary data to be posted on FDA website for interim and final reports include:
Aortic-related mortality
All-cause mortality
Aneurysm rupture
Aneurysm enlargement (>5mm)
Major Adverse Events
All types of endoleaks
Graft migration (>10mm)
Stent fracture and graft occlusion (including stenosis and kink)
Conversion to open surgery
Secondary interventions
Technical Success
|
| Follow-up Visits and Length of Follow-up |
A minimum of 5 years
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