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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P210006 / PAS001 |
| Date Original Protocol Accepted |
08/08/2022
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| Date Current Protocol Accepted |
|
| Study Name |
EXTEND Post-Approval Study
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| Device Name |
Thoraflex™ Hybrid
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
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| Analysis Type |
Descriptive
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The Thoraflex Hybrid and Relay Extension Post-Approval Study (EXTEND) is a prospective, multi-center, non-randomized, single arm, post-market study. The objective of the study is to collect real-world safety and effectiveness outcomes the Thoraflex Hybrid device alone and in combination with the RelayPro NBS stent-graft in the treatment of aortic disease affecting the aortic arch and descending aorta, with or without involvement of the ascending aorta.
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| Study Population |
Patients who undergo treatment with the Thoraflex Hybrid device, with or without extension with a RelayPro NBS stent-graft (all-comers population).
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| Sample Size |
A minimum of 200 subjects will be enrolled, with a minimum of 65 subjects with the RelayPro NBS distal extension. Subjects will be enrolled at up to 55 study sites across Europe and North America, with at least 50% of enrolled subjects from the USA.
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| Key Study Endpoints |
The primary safety endpoint is a composite of the following:
1) Permanent disabling stroke (mRS >2 and an increase in at least one mRS category from the individual’s pre-stroke baseline, occurring within 30 days of either index procedure or extension and present at 1-year follow-up)
2) Grade 3 spinal cord ischemia occurring within 30 days of either index procedure or extension
3) All-cause mortality (within 1 year of either index procedure or extension)
The primary effectiveness endpoint is Treatment Success, which is defined as device technical success (of either procedure) with the absence of the following at 1-year:
Lesion-related mortality
Aortic rupture in the treated segment
Lesion expansion (greater than or equal to 5mm increase from measurement at discharge/within 30 days)
Secondary intervention to address the following:
Stent graft-induced aortic wall injury (SAWI)
Fistula
Type I or III endoleak (see definitions)
Migration
Loss of Patency
Thromboembolic events
Failure of integrity
Additional secondary safety and effectiveness endpoints will be collected and reported at each follow-up point through 10 years post-procedure.
Secondary Safety Endpoints
All-cause mortality
Lesion-related mortality
All/any paraplegia/paraparesis defined as SCI (SVS grades 1 to 3)
Any stroke (excluding TIA)
Incidence of Myocardial Infarction
Incidence of Respiratory Failure
Incidence of Renal Failure
Incidence of Bowel Ischemia
Secondary Effectiveness Endpoints
Any aortic rupture (treated and untreated segments)
Aortic remodeling in the treated segment(s)
New dissections
Proximal and distal extension of dissections
Any false lumen perfusion (specifying location and if intentional or not)
Fistula formation
All endoleaks
Device migration
Device integrity issues (e.g., stent fracture)
All thromboembolic events
Pseudoaneurysms (device-related)
Secondary Interventions
Graft patency (loss of patency will be defined as an opening of <50% due to, for example, occlusion, stenosis, kinking)
|
| Follow-up Visits and Length of Follow-up |
10 years
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
4
|
| Actual Number of Sites Enrolled |
7
|
| Patient Follow-up Rate |
3/3 (100%) of eligible subjects have completed the discharge/30 day follow-up visit. One of the 4 enrolled subjects (25%) died prior to
the 30 day follow-up visit.
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| Final Safety Findings |
NA
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| Final Effect Findings |
NA
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