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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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EXTEND Post-Approval Study


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General
Study Status Ongoing
Application Number /
Requirement Number
P210006 / PAS001
Date Original Protocol Accepted 08/08/2022
Date Current Protocol Accepted  
Study Name EXTEND Post-Approval Study
Device Name Thoraflex™ Hybrid
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
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.
Study Population Patients who undergo treatment with the Thoraflex Hybrid device, with or without extension with a RelayPro NBS stent-graft (all-comers population).
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.
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


EXTEND Post-Approval Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 10/18/2022 10/13/2022 On Time
1 year report 04/19/2023    
18 month report 10/18/2023    
2 year report 04/18/2024    
3 year report 04/18/2025    
4 year report 04/18/2026    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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