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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P180013 / PAS001 |
| Date Original Protocol Accepted |
05/02/2019
|
| Date Current Protocol Accepted |
05/29/2020
|
| Study Name |
VIRTUS Continued Follow-up Study
|
| Device Name |
VICI VENOUS STENT System
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Other Data Source
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| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The objective of this study is to evaluate the long-term safety and effectiveness of the VICI VENOUS STENT System.
|
| Study Population |
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.
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| Sample Size |
The continued follow-up study will evaluate all 163 remaining subjects who were active at the end of the 12-month evaluation.
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| Key Study Endpoints |
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)
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| Follow-up Visits and Length of Follow-up |
The follow-up period is 36 months
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
A total of 200 subjects were enrolled in the VIRTUS Trial, including 30 subjects in the feasibility cohort and 170 subjects in the pivotal cohort.
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| Actual Number of Sites Enrolled |
Total of 31 sites: 9 sites in the U.S. and Europe enrolled subjects for the feasibility study, and 22 sites in the U.S. and Europe enrolled subjects for the pivotal study.
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| Patient Follow-up Rate |
79.0% (158/200) and 72.5% (145/200) at 24 and 36 months, respectively for the total cohort.
|
| Final Safety Findings |
Overall rate of major adverse events at 24 and 36 months was 3.2% (6/187) and 5.2% (9/172) respectively
Death rate at 24 and 36 months was 0.5% (1/187) and 2.3% (4/172) respectively. Device or procedure related death through 36 months was 0% (0/200).
Deep venous thrombosis rate at 24 and 36 months was 0.5% (1/187) and 1.7% (3/172) respectively.
Suspected or confirmed pulmonary embolism rate at 24 and 36 months was 0.5% (1/187) and 1.7% (3/172) respectively.
Stent movement (dislodgement and migration) as adjudicated by the Clinical Event Committee through 36 months was 0% (0/200).
A total of 344 serious adverse events were reported. The reported of rate of subjects with a serious adverse event was 50% (100/200).
Overall stent fracture rate was 3.3% (11/332) for the total implanted stents. Ten (10) of the 11 fractures occurred in the common femoral vein and one fracture occurred in the common iliac vein. One subjects with stent fracture underwent a target vessel revascularization. There were no clinical complications associated with any of the fractures.
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| Final Effect Findings |
Primary patency assessed by duplex ultrasound (DUS) at 24 and 36 months was 79.7% (110/138) and 71.7% (86/120) respectively.
Freedom from target vessel revascularization rate at 24 and 36 months was 89.2% (166/186) and 87.0% (147/169) respectively.
Primary assisted patency rate by DUS at 24 and 36 months was 94.8% (128/135) and 93.8% (105/112)
respectively.
Secondary patency rate by DUS at 24 and 36 months was 97.0% (130/134) and 96.4% (106/110)
respectively.
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| Study Strengths & Weaknesses |
Study Strength: This study is a multicenter study that enrolled 31 investigational sites (22 pivotal and 9 feasibility sites) in the US and Europe. The study met the primary effectiveness endpoint (primary patency rate of 84% at 12 months compared to the performance goal (PG) of 72.1%, p<0.0001). Similarly, the primary safety endpoint of freedom from major adverse event rate within 30 days was met (98.8% freedom from MAE with lower 95% confidence limit of 95% compared to PG of 94%). Clinical Follow-up was completed for nearly 80% of overall subjects at 24 months and over 70% at 36 months.
Weakness: This is a non-randomized study with inherent biases.
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| Recommendations for Labeling Changes |
Labeling change is recommended to reflect the long-term results of the post-approval study (pivotal and feasibility cohorts). The labeling change should include a new section on the label showing a summary of the post- approval study results (final endpoint results, follow-up rate etc.), strengths and limitations of the PAS.
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