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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P230021 / PAS001 |
| Date Original Protocol Accepted |
12/26/2023
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| Date Current Protocol Accepted |
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| Study Name |
VIVID Continued Follow-up Study
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| Device Name |
Duo Venous Stent System
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| Clinical Trial Number(s) |
NCT04580160
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Transit. Adolescent A (distinctively) : 18-21 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
To evaluate the long-term safety and effectiveness of the Duo Venous Stent System. The study is a prospective, multi-center follow-up of the VIVID (G190030) that enrolled 162 subjects from 30 investigational sites in the United States and European Union.
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| Study Population |
All remaining subjects treated with Duo Venous Stent System in the VIVID trial active at the end of 12 months evaluation.
There is no comparator group for the continued follow-up study.
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| Sample Size |
One hundred and fifty two (152) active subjects from the VIVID IDE trial.
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| Key Study Endpoints |
Endpoints to be assessed at 24 and 36 months include:
• Freedom from clinically driven target lesion revascularization (CD-TLR)
• Primary patency
• Primary assisted patency
• Secondary patency
• Stent fracture, migration, and embolization
• Changes in CEAP, Villalta, VCSS pain score, and VEINES QOL
• Venous Ulcer Assessment
• Clinically driven target vessel revascularization (CD-TVR)
• Adverse Events
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| Follow-up Visits and Length of Follow-up |
3 years
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
162
- Non-thrombotic – 104 subjects
- Acute thrombotic – 16 subjects
- Chronic post-thrombotic– 42 subjects
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| Actual Number of Sites Enrolled |
32
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| Patient Follow-up Rate |
77.2% (125/162) at 24 months
73.5 (119/162) at 36 months
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| Final Safety Findings |
Kaplan Meier (KM) estimate of freedom from MAEs in the ITT population was 89.7% (95% CI: 82.8, 94.0) at 36 months.
KM estimate of freedom from CD-TLR and CD-TVR at 36 months in ITT population was 91.1% (95% CI: 84.4, 95.0) and 90.5% (95% CI: 83.7, 94.5) respectively.
Venous Ulcer Assessment:
For venous ulcers present at baseline or new during follow-up, most improved into the “dressed”, “healed”, or “improved” categories and no wounds were rated at “worsened” and “amputated”.
Only two subjects developed new wounds during the 12- month period and two subjects had new wounds develop during the 24- to 36-month follow-up period.
There were no unanticipated adverse device events
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| Final Effect Findings |
Primary Effectiveness Endpoint:
Primary patency at 24 months and 36 months in the ITT Subjects was 90.0% (108/120) and 86.1% (87/101) respectively.
Secondary Effectiveness Endpoints
Primary assisted patency in the ITT subjects was 95.8% (113/118) [95% CI:90.4, 98.6] at 24-
months and 96.9% (94/97) [95% CI: 91.2, 99.4] at 36 months.
Secondary patency in the ITT subjects at 24 and 36 months was 97.5% (115/118) [95% CI: 92.7, 99.5] and 96.9% (94/97) [95% CI: 91.2, 99.4] respectively.
Through the 36-month follow-up, there were no stent fractures, migration or embolization.
CEAP classification improved from baseline to 12-, 24-, and 36-months. At baseline
97.6% of ITT subjects were scored in the more severe CEAP categories: C3 –
Edema; C4 – Change in skin and subcutaneous tissue secondary to chronic venous
disease; C5 – Healed; and C6 – Active venous ulcer.
At 24 months, 52% (66/126) were in the C0-C2
categories. At 36 months, 59% (68/115) were in the C0-C2 categories
ITT subjects showed significant improvement from baseline to 12 months in all five
dimensions of the EQ-5D-3L score (p<0.0171) and the EQ-VAS health state score
(p<0.0001). Positive changes were sustained through 36-month follow-up.
The Villalta score significantly improved (p<0.0001) from a baseline median score of
10 (range 1-23) which was in the mild/moderate PTS severity range to a 12-month
median of 2 (range 0-20), which was in the no PTS range. Through 36 months positive changes were sustained (<0.0001).
The VEINES SYM scale score in ITT subjects significantly improved (p<0.0001) from
a median score at baseline of 51 (range 2-100) to 83 (range 9-100) at 12 months. The
VEINES QOL scale in ITT subjects also significantly improved (p<0.0001) from a
median baseline score of 52.5 (range 2.1-96.5) to a median score at 12 months of
82.7 (range 12.7-100.0). Positive changes were sustained through 36-month follow-up
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| Study Strengths & Weaknesses |
This was a prospective, multi-center, single-arm study. The study met both primary safety and effectiveness endpoints. The freedom from MAEs (FAS cohort) at 30 days was 98.7% with lower 95% confidence bound of 95.5% versus 89% performance goal, PG (p<0.0001).
Primary patency at 12 months (FAS cohort) was 90.2% with a 95% lower confidence bound of 83.1% versus 77.3% PG (p=0.0002).
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| Recommendations for Labeling Changes |
Labeling update is recommended with long-term results of the VIVID Continued Follow-up study.
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