Status:
COMPLETED
Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery
Lead Sponsor:
Cook Group Incorporated
Collaborating Sponsors:
William Cook Europe
MED Institute, Incorporated
Conditions:
Peripheral Vascular Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The Zilver® PTX™ Drug Eluting Vascular Stent is indicated for the treatment of symptomatic vascular disease of the above-the-knee femoropopliteal artery (ranging from 4 mm to 9 mm in reference vessel ...
Detailed Description
The Zilver® PTX™ Drug Eluting Vascular Stent is indicated for the treatment of symptomatic vascular disease of the above-the-knee femoropopliteal artery (ranging from 4 mm to 9 mm in reference vessel ...
Eligibility Criteria
Inclusion
- Patient has signed and dated the informed consent.
- Patient has up to 2 documented stenotic or occluded atherosclerotic lesions (up ro 14 cm long) of the above-the-knee femoropopliteal artery, up to one in each limb, that meet all of the inclusion criteria and none of the exclusion criteria.
- Patient has a de novo or restenotic lesion(s) with \>50% stenosis documented angiographically and no prior stent in the target lesion.
- Patient has symptoms of peripheral arterial disease classified as Rutherford Category 2 or greater.
- Patient has a resting Ankle Brachial Index (ABI) \<0.9 or an abnormal exercise ABI if resting ABI is normal. Patient with incompressible arteries (ABI \>1.2) must have a Toe Brachial Index (TBI) \<0.8.
- Patient agrees to return for a clinical status assessment and duplex ultrasound at 6 months, 12 months, and at 2, 3, 4, and 5 years.
- Patient agrees to return for x-rays at 6 and 12 months.
- Patient agrees to return for angiography at 12 months.
- Patient agrees to be contacted by telephone at 1, 3, 9, and 18 months to assess clinical status.
Exclusion
- Patient is pregnant or breast-feeding.
- Patient is simultaneously participating in another investigational drug or device study.
- Patient has significant stenosis or occlusion of inflow tract not successfully treated before this procedure.
- Patient has any planned surgical or interventional procedure within 30 days after the study procedure.
- Patient has had previous stenting of target vessel.
- Patient in whom antiplatelet and/or anticoagulant therapy is contraindicated.
- Patient has known hypersensitivity or contraindication to aspirin, antiplatelet medication, contrast dye, paclitaxel or nitinol and, in the opinion of the investigator, cannot be adequately premedicated.
- Patient lacks at least one patent vessel of runoff with \<50% stenosis throughout its course.
- Patient has untreated angiographically-evident thrombus in the target lesion.
- \[Additional criteria may apply.\]
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
474 Patients enrolled
Trial Details
Trial ID
NCT00120406
Start Date
March 1 2005
End Date
February 1 2014
Last Update
August 11 2014
Active Locations (52)
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1
El Camino Hospital
Mountain View, California, United States, 94040
2
Tri-City Medical Center
Oceanside, California, United States, 92056
3
Stanford University Hospital and Clinics
Stanford, California, United States, 94305
4
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010