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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P100022 / PAS001 |
| Date Original Protocol Accepted |
11/14/2012
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| Date Current Protocol Accepted |
02/15/2013
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| Study Name |
New US Enrollment
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| Device Name |
ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
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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 |
Objective Performance Criterion
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| Analysis Type |
Analytical
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| 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, multicenter study of newly enrolled U.S. patients.
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| Study Population |
Patients with symptomatic vascular disease of the native above-the-knee femoro-popliteal arteries with a reference vessel diameter 4- 7 mm and total lesion lengths up to 140 mm per limb and 280 mm total.
The study has no control group. The comparator is performance goal of
83.1% at 1 year.
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| Sample Size |
200 new patients enrolled from a minimum of 10 sites across the United
States.
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| Key Study Endpoints |
Primary Endpoint: Target lesion Revascularization (TLR) at 1 year. Secondary Endpoints: thrombosis, stent fracture other adverse events.
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| Follow-up Visits and Length of Follow-up |
1 year
TLR assessment at 1 year.
Stent thrombosis and other adverse events assessments at pre-discharge and 1 year.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
A total of two hundred (200) patients were enrolled for this PAS. This includes 149 patients treated with
stents less than or equal to 80 mm in length and 51 patients treated with stents greater than or equal to 100 mm in length.
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| Actual Number of Sites Enrolled |
Seventeen (17) investigational sites were enrolled across the United States for the post -approval study (US PAS).
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| Patient Follow-up Rate |
One hundred and ninety-four (194) of the 200 enrolled patents were eligible for 12 months visit and 175 patients completed the follow-up at 12 months for a rate 90.2% (175/194).
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| Final Safety Findings |
safety and effectiveness endpoints:
All patients
The 12-month freedom from target lesion revascularization (TLR) rate in patients treated with the Zilver PTX stent (91.8%, 95% confidence interval:87.2%, 94.8%) met the non- inferiority performance goal of 83.1% (z test statistics, p<0.001).
Study lesion thrombosis rate at 12 months was 2.5% (5/200). Stent fracture rate at 12 months was 0.4 (1/276).
The rate of amputation of study limb at 12 months was 2.5% (5/200).
The rate of worsened claudication/rest pain at 12 months was 13.5% (27/200).
Subgroups: Short stent group- patients treated with stents less than or equal to 80 m m in length vs. long stent group- patients treated with stents greater than or equal to 100 mm in length
The Kaplan-Meier estimates for freedom from TLR at 12 months for patients treated with stents less than or equal to 80 mm in length and those treated with stents greater than or equal to 100 mm in length were 91.9% and 92.2%, respectively (p=0.94, Log-Rank test), indicating no significant difference in the TLR rates between the subgroups.
The 12-month rate of study lesion thrombosis was 2.7% (4/149) for the short stent group and 2.0% (1/51) for the long stent group (p > 0.99).
Stent fracture rate at 12 months was 0.5% (1/214 stents) for the short stent group and 0% (0/62 stents) for the long stent group (P > 0.99).
The rate of amputation of study limb at 12 months was 3.4% (5/149) for the short stent group and 0% (0/51) for the long stent group.
The rate of worsened claudication/rest pain at 12 months was 14.8% (22/149) for the short stent group and 9.8% (5/51) for the long stent group.
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| Study Strengths & Weaknesses |
This was a single-arm, non-randomized multicenter study involving United States patients with follow- up up to 12 months (available patients will be followed through 5 years in the Zilver PTX Stent PAS or PAS2). The follow up rate at 12 months exceeded 80%. The study met the primary endpoint hypothesis with freedom from TLR rate greater than the 83.1% performance goal, therefore confirms the safety and effectiveness of the Zilver PTX stent in the post-approval setting.
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| Recommendations for Labeling Changes |
Labeling change is recommended to reflect the data from the post-approval study. The labeling change should include a new section in the label showing a summary of the post Approval study methods (including study objectives, design, population, number of enrolled sites/subjects, key endpoints, follow
–up visits etc.), results and study strengths and limitations.
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