This randomized clinical study is intended to evaluate the use of Zilver PTX stents for treatment of thigh atherosclerosis. Research question: Is there an adjuvant benefit of angioplasty and stenting using the new paclitaxel eluting stent, Zilver-PTX, over risk factor modification and medical therapy alone in patients with stable, mild to moderate intermittent claudication caused by femoropopliteal lesions suitable for endovascular management.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Angioplasty and stenting with a polymer free paclitaxel-eluting stent (Zilver-PTX)
Treatment with antiplatelet and statins, smoking cessation advice and unsupervised walking exercise.
Rigshospitalet
Copenhagen, Østerbro, Denmark
RECRUITINGMaximal walking distance
Walking distance will be quantified by standardized treadmill testing using constant speed of 3 km per hour with no incline for a maximum of 5 minutes.
Time frame: 24 months
Ankle brachial pressure indices
a measure of the peripheral bloodpressure
Time frame: 24 months
Quality of life
Quality of life is evaluated by using questionnaires
Time frame: 24 months
Cost of the treatment
Time frame: 24 months
Torben V Schroeder, MD, MDSc
CONTACT
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