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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P100022 / PAS002 |
| Date Original Protocol Accepted |
11/14/2012
|
| Date Current Protocol Accepted |
01/13/2015
|
| Study Name |
Zilver PTX Stent PAS
|
| Device Name |
ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
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| 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
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| Detailed Study Protocol Parameters |
| Study Objectives |
A prospective, single-arm, multi-center study. Includes all subjects from the new US enrollment study, the Zilver PTX subjects from the premarket study, the Japanese post-approval study.
|
| Study Population |
Comprises of PAS 1 subjects, the Zilver PTX subjects from the pivotal study, and earliest sequentially enrolled subjects in the Japan PAS that are consistent with the US PAS selection criteria with the exception that lesion length per limb may extend up to 200 mm.
Patients with symptomatic vascular disease of the native above-the-knee femoropopliteal arteries with a reference vessel diameter 4 to 7 mm and total lesion lengths up to 140 mm per limb and 280 mm total will be enrolled; for patients enrolled from the Japan PAS, lesion length per limb may extend up to 200 mm.
|
| Sample Size |
The sample size will comprise of 200 patients from the new US Enrollment enrolled from minimum of 10 sites, 300 premarket RCT patients enrolled at
47 sites in the US, and approximately 400 patients from the Japan
postmarket study enrolled at 60-90 sites.
|
| Key Study Endpoints |
Target lesion revascularization (TLR), patency by duplex ultrasonography, and stent thrombosis assessed annually through 5 years in 900 subjects.
Stent integrity assessed by x-ray imaging at 1, 3, and 5 years in 600 patients.
|
| Follow-up Visits and Length of Follow-up |
5 years
Annual follow-up through 5 years
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
Combined Cohort - 904
Pivotal – 305
Japanese Post-Approval Study – 399
US Post-Approval Study - 200
|
| Actual Number of Sites Enrolled |
Combined Cohort – 158
Pivotal – 52
Japanese Post-Approval Study – 89
US Post-Approval Study - 17
|
| Patient Follow-up Rate |
Combined Cohort
Baseline 100% (904/904);
1 Year 96.3% (810/841);
2 Years 93.0% (681/732);
3 Years 92.9% 588/633);
4 Years 94.0% (513/546)
5 Years 451 completed study
Pivotal
Baseline 100% (305/305);
1 Year 98.2% (277/282);
2 Years 93.1% (228/245);
3 Years 95.7% (198/207);
4 Years 91.3% (167/183)
5 Years 146 completed study
Japanese PAS
Baseline 100% (399/399);
1 Year 97.6% (359/368);
2 Years 94.0% (297/316);
3 Years 90.9% (250/275)
|
| Final Safety Findings |
Safety endpoints assessed for the combined cohort included:
adverse events,
occurrence of TLR,
thrombosis, and
stent integrity through 5 years.
The primary safety hypothesis was freedom from TLR at 12-months against a performance goal of 83.1%.
12-month TLR rate of 91.8% met the non-inferiority performance goal of 83.1% (p < 0.0001).
5-year freedom from TLR rate - 80.8%.
Through 5 years, the freedom from thrombosis rate - 96.5%.
Stent integrity was assessed by X-ray at 1, 3, and 5 years.
5-year freedom from stent fracture rate of 98.5%
1 year – 3 fractures total
3 years – 12 fractures total
5 years – 14 fractures total
> 5 years – 16 fractures total
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| Final Effect Findings |
Effectiveness endpoint for the combined cohort was primary patency assessed by duplex ultrasound (PSVR < 2.0). Patency data were only available for the pivotal and US PAS studies; patency assessment was not required in the Japanese PAS.
5-year primary patency estimate - 59.3%.
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| Study Strengths & Weaknesses |
The follow-up compliance and study deviations were within reasonable expectations
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| Recommendations for Labeling Changes |
Additional information is available from these results that supplements information already contained in the publicly available SSED and labeling. Therefore, labeling changes are recommended
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