Peripheral Arterial Disease (PAD)
Conditions
Brief summary
The purpose of this study is to assess the ability of a vascular stent to maintain an open iliac (leg) artery. The Zilver Vascular Stent is made of nitinol, a flexible metal with a long history of use in medical devices. The stent self-expands once inside the artery where it is intended to hold the vessel wall open. Within a few weeks, a layer of cells will grow over the stent helping to hold it in place.
Interventions
DEVICEPeripheral Vessel Stenting
Sponsors
Cook Group Incorporated
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient has documented stenotic or occluded atherosclerotic lesions of the external iliac or common iliac artery. * Patient has a de novo or restenotic lesion(s) with no prior stent in the target lesion. * Patient has given informed consent.
Exclusion criteria
* Patient is less than 50 years of age * Patient is participating in another investigational drug or device study. * Patient has multiple lesions (ipsilateral or in the aorta) that would require a staged procedure. * Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions. * Patient has a known hypersensitivity or contraindication to aspirin, clopidogrel, nitinol, or contrast dye that cannot be adequately premedicated. * Patient is pregnant or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is major adverse event (MAE) rate at the 9-month follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional endpoints include acute procedure and hemodynamic success, secondary patency, 9-month restenosis rate based on ultrasound examination, and 9-month functional status improvement. | — |
Outcome results
None listed