Clinical Research Directory

Inclusion Criteria: * Patients with femoro-popliteal artery disease, who will require a stent femoro-popliteal following failed percutaneous transluminal angioplasty (PTA) * Target Lesion length \<200mm * Planned follow-up available for at least 24 months * Written informed consent to participate in the study and agreement to comply with the study protocol must be obtained from the patient prior to initiation of any study-mandated procedure and randomization Exclusion Criteria: * Life expectancy \<24 months * Patients who cannot receive dual antiplatelet therapy (aspirin 100mg and clopidogrel 75mg) or anticoagulation therapy * Patients with known allergies to: nitinol (nickel titanium); or contrast agent, that cannot be medically managed * Participation in another study with investigational drug/device within the 30 days preceding and during the present study * Previous enrolment into the current study * Prior stenting at the location of intended stenting * Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system * Enrolment of study investigator, his/her family members, employees and other dependent persons * If female and of childbearing potential: known pregnancy or a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating