Post-Approval Studies (PAS) Database

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

General
Study Status	Completed
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
Clinical Trial Number(s)	NCT03241459
General Study Protocol Parameters
Study Design	Randomized Clinical Trial
Data Source	New Data Collection
Comparison Group	Concurrent Control
Analysis Type	Descriptive
Study Population	Adult: At least 22 yrs
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
Interim or Final Data Summary
Actual Number of Patients Enrolled	446
Actual Number of Sites Enrolled	79
Patient Follow-up Rate	Approximately 85-92%
Final Safety Findings	91.8% Surveil vs 89.8% for the IN.PACT
Final Effect Findings	82.2% Surveil vs 85.9% for the IN.PACT
Study Strengths & Weaknesses	Strengths: RCT, long term follow up Weaknesses: Follow up complacence (withdrawals) in the test arm
Recommendations for Labeling Changes	Update to reflect the new data at 5 years

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	06/11/2024	On Time
final report	06/15/2025	12/11/2024	On Time

Contact Us

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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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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background