Peripheral Arterial Disease (PAD)
Conditions
Brief summary
This randomized multi-center study is intended to compare different coatings on stents for treatment of lesions of the above-the-knee femoropopliteal artery.
Interventions
DEVICEZilver® Paclitaxel-Eluting Peripheral Stent
Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.
DEVICEZilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating
Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.
DEVICEZilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating
Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.
Sponsors
Cook Group Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* One de novo or restenosed artherosclerotic lesion with ≥ 50% diameter stenosis * Symptoms of peripheral arterial disease (Rutherford 2-4)
Exclusion criteria
* Pregnant, breastfeeding, or planning to become pregnant in the next 5 years * Less than 18 years old * Medical condition or disorder that would limit life expectancy to less than 12 months or that may cause noncompliance with the protocol or confound the data analysis * Previous stent in the study vessel
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percent diameter stenosis within the study lesion evaluated by conventional angiography. | 6 months | Percent diameter stenosis will be calculated by comparing the minimal lumen diameter to the average of the proximal and distal reference vessel diameters. |
Countries
Germany, New Zealand
Outcome results
None listed