f Post-Approval Studies (PAS) Database
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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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TRANSCEND Continued Follow-up Study


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General
Study Status Ongoing
Application Number /
Requirement Number		 P210025 / PAS001
Date Original Protocol Accepted 06/16/2023
Date Current Protocol Accepted  
Study Name TRANSCEND Continued Follow-up Study
Device Name SurVeil Drug-Coated Balloon
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives To show sufficient long term safety and effectiveness of the SurVeil DCB for use in superficial femoral or popliteal arteries.
The study was designed as a global, multicenter, single blind, randomized trial.

This study is continued follow-up of premarket cohorts.
Study Population Adult patients with PAD
Sample Size N=446 (n=222 Surveil DCB; n=224 IN.PACT Admiral DCB)
Key Study Endpoints The primary safety endpoint was a composite of freedom from device- and procedure-related death through 30 days post-index procedure and freedom from major target limb amputation (above the ankle) and clinically-driven target vessel revascularization (TVR) through 12 months post-index procedure.

The primary effectiveness endpoint was primary patency, defined as a composite of freedom from clinically-driven TLR and binary restenosis (restenosis defined as DUS peak systolic velocity ratio [PSVR] greater than or equal to 2.4 or greater than or equal to 50% stenosis as assessed by independent angiographic and DUS core labs) through 12 months post-index procedure.
Follow-up Visits and Length of Follow-up 5 years annually


TRANSCEND Continued Follow-up Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 12/15/2023 12/13/2023 On Time
1 year report 06/15/2024    
2 year report 06/15/2025    
3 year report 06/15/2026    
4 year report 06/15/2027    
5 year report 06/14/2028    


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

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