1. Does primary stenting have a lower 12-month restenosis rate than PTA alone in the treatment of atherosclerotic lesions of the popliteal artery? * Alternative hypothesis: "Primary stenting with the Edwards LifeStent is associated with a lower restenosis rate than PTA alone in patients with atherosclerotic lesions of the popliteal artery at 12 months" * Null hypothesis: "Primary stenting with the Edwards LifeStent is not associated with a lower 12-month restenosis rate than PTA alone in patients with atherosclerotic lesions of the popliteal artery"" 2. Does comparison of the two intervention groups (PTA alone, stenting) disclose differences in terms of the secondary endpoints? 3. How do the intervention methods compare in terms of safety/incidence of adverse effects? 4. What are the long-term clinical implications of the two treatment methods?
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
Stent for endovascular treatment of popliteal artery lesions
PTA for endovascular treatment of popliteal artery lesions
Herzzentrum Bad Krozingen
Bad Krozingen, Germany
RECRUITINGUniversitäres Herzzentrum Hamburg
Hamburg, Germany
RECRUITINGRestenosis rate (duplex ultrasound or angiographic stenosis >50% of vascular lumen diameter; PVR > 2.4 m/s)
Time frame: 12-month
Primary patency
Time frame: 12 and 24 months
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