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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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VERNACULAR Cont F/u PAS


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General
Study Status Study Pending
Application Number P180037 / PAS001
Study Name VERNACULAR Cont F/u PAS
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 Design Description The objective of this post approval study (VERNACULAR Continued Follow-Up Study) is to evaluate the long term safety and effectiveness of the VENOVO Venous Stent System for the treatment of symptomatic iliofemoral venous outflow obstruction. This study is a prospective, multi-center follow-up of the VERNACULAR pivotal study (G150248).
Study Population Description The study population included patients with symptomatic (non-malignant) venous outflow obstruction in iliofemoral venous segments of greater than or equal to 50% as determined by catheter contrast venography.
Sample Size All 160 remaining subjects (10 subjects have discontinued the study) of the 170 original study subjects enrolled from 22 investigational sites.
Data Collection Primary Endpoint:

Freedom from target lesion revascularization (TLR) at 36 months.



Secondary Endpoints:

Overall rate and incidence of type of serious adverse events from Day 0 through completion of Study follow-up at Month 36.

Primary stent patency rate: determined at Month 24 and Month 36 per protocol definition of primary stent patency.

Freedom from target lesion revascularization (TLR) at Month 24 and Month 36, as defined by the protocol.

Freedom from target vessel revascularization (TVR) at Month 24 and Month 36, as defined by the protocol.

Comparison of VCSS Scores measured at Baseline, Month 12, Month 24 and Month 36.

Comparison of Quality of Life Questionnaire (QOL) Scores measured at Baseline, Month 12, Month 24 and Month 36.

Comparison of CEAP Scores measured at Baseline, Month 12, Month 24 and Month 36.

Stent integrity measured as freedom from stent fracture, defined as clear interruption of a stent strut observed in a minimum of two projections, determined by core lab examination of X-rays at 24 and 36 Months.

Follow-up Visits and Length of Follow-up 36 months


VERNACULAR Cont F/u PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 03/12/2020    
two year report 03/12/2021    
three year report 03/12/2022    
four year report 03/12/2023    


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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