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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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VIRTUS Continued Follow-up Study


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General
Study Status Study Pending
Application Number P180013 / PAS001
Date Current Protocol Accepted  
Study Name VIRTUS Continued Follow-up Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Detailed Study Protocol Parameters
Study Design Description The objective of this study is to evaluate the long-term safety and effectiveness of the VICI VENOUS STENT System.



Study Population Description Subjects considered for enrollment were 18 years of age or older and had the presence of unilateral, clinically significant, chronic non-malignant obstruction of the common femoral vein, external iliac vein, common iliac vein, or any combination thereof, where obstruction is defined as a greater than or equal to50% reduction in the target vessel lumen diameter as measured by venography during the index procedure.



A total of 127 subjects had prior venous obstruction associated with thromboembolic disease and were referred to as post-thrombotic (PT) subjects. A total of 43 subjects had iliofemoral venous segment obstruction without previous thromboembolic or intraluminal disease and were referred to as non-thrombotic (NT) subjects.



Sample Size The continued follow-up study will evaluate all 163 remaining subjects who were active at the end of the 12-month evaluation.



Data Collection Primary endpoint: primary patency by duplex ultrasound (DUS) at 3 years.

Secondary endpoints:

Overall rate and incidence of major adverse events through 3 years

Overall rate and incidence of serious adverse events through 3 years

Freedom from target vessel revascularization (TVR) at 2 years and 3 years, defined as freedom from any re-intervention in the target vessel segment and freedom from thrombosis/stenosis > 50% as measured by DUS

Primary assisted stent patency rate at 2 years and 3 years, defined as patency regardless of whether an intervention (subsequent to the index procedure) was performed to maintain patency

Secondary stent patency rate at 2 years and 3 years, defined as freedom from permanent loss of patency determined through last follow-up (regardless of the number of interventions)



Follow-up Visits and Length of Follow-up at least 3 years


VIRTUS Continued Follow-up Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 05/01/2020    
two year report 05/01/2021    
three year report 05/01/2022    
four year report 05/01/2023    
five year report 04/30/2024    


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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