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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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VERNACULAR Cont F/u PAS


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General
Study Status Completed
Application Number P180037 / PAS001
Date Current Protocol Accepted  
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
Interim or Final Data Summary
Actual Number of Patients Enrolled One hundred and seventy (170) subjects were enrolled and treated with the study device
Actual Number of Sites Enrolled Twenty-two (22) investigational sites enrolled and treated subjects.
Patient Follow-up Rate 75.3% (128/170) of subjects completed follow-up at 36 months
Final Safety Findings The primary safety endpoint was freedom from MAEs through 30 days (defined as target vessel
revascularization, device and/or procedure related death, major amputation of target limb, pulmonary
embolism, vascular injury, embolization/migration of stent and device or procedure related DVT of
treated limb). The proportion of subjects free from MAE was 93.5% [90% CI: 89.5%,96.3%] compared to
literature-derived PG of 89% (1-sided p-value = 0.0322).

Key Secondary Endpoints with Hypothesis Testing
At 12 month the Venous Clinical Severity Score (VCSS) pain score change from baseline in the total
study population was -1.7 [95% CI: -1.81 to -1.49 (P < .0001).
At 36 month the VCSS pain score change from baseline in the total study population was -1.8 [95% CI: -
1.95 to -1.66].
At 12-month Quality of Life (QoL) assessment of Chronic Venous Insufficiency Questionnaire (CIVIQ-20)
change from baseline in the total study population was -15.7 [ 95% CI: -18.41 to -12.96] (P < .0001).
At 36 months total CIVIQ-20 Score change from baseline in the total study population was – 16.8 [95%
CI: -20.07 to -13.54].

Secondary Endpoints Without Hypothesis Testing
Freedom from TLR rates for the study population at 24 and 36 months was 89.4% and 88.1%
respectively.
The freedom from TVR rates for study population at 24 and 36 months was 89.4% and 88.1%,
respectively. Freedom from TLR and freedom from TVR results are the same through the 36-month
analysis as all TLRs were also TVRs.
Freedom from stent fracture from Xray analysis by the Core Lab through 36 months was 100%.
There was one (1) reported device deficiency that was not associated with an adverse event.
This was resolved by post-dilatation inside the stent and the subject did not experience any adverse
events through the 36-month follow-up period.
A total of 6 deaths were reported. All deaths were adjudicated by the CEC to be not related to the study
device or procedure.
One (1) subject underwent a planned target limb amputation (1/170, 0.6%). The amputation was
adjudicated by the CEC to be not related to the study device or procedure.
Final Effect Findings The primary effectiveness endpoint was primary patency at 12 months post-index procedure (defined as
freedom from TVR and freedom from thrombus occlusion and stenosis > 50% as measured by DUS). The
12-month weighted primary patency rate for the Stent group was 88.6%, 90% CI [82.8%, 94.4%],
compared to a literature derived PG of 74% (1-sided p-value <0.0001).
Primary endpoint for the post approval study was freedom from target lesion revascularization (TLR) at
36 months per protocol definition. Freedom from TLR at 36 months (unweighted) was 84.0% [90%
CI:78.2%, 88.3%]
Study Strengths & Weaknesses This was a multicenter study that enrolled 22 investigational sites in the US, Europe and Australia. The
study met the primary effectiveness endpoint (primary patency rate of 88.6% at 12 months compared to
the performance goal (PG) of 74%%, one-sided p<0.0001). Similarly, the primary safety endpoint of
freedom from major adverse event rate at 30 days was met (freedom from MAE rate of 93.5% with 90%
CI of 89.5% to 96.3% compared to PG of 89%). Follow-up was completed for 75.3% of subjects at 36
months.
Recommendations for Labeling Changes Labeling change is recommended to update the labeling with the long-term results of the post-approval
study. The labeling change should include a new section on the label showing a summary of the postapproval study results (final endpoint results, follow-up rate etc.), strengths and limitations of the PAS.


VERNACULAR Cont F/u PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
final report 05/13/2021 05/14/2021 Overdue/Received


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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