PTA and Drug Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia

Inclusion Criteria: * Written informed consent * Age \> 18 years * If female patient with child bearing potential, patient may not be pregnant at the study entry and must utilize reliable birth control for the duration of her participation into the study * Patient is willing and able to comply with the specified follow-up evaluation * Critical Limb Ischaemia, this is Fontaine stage III (ischaemic rest pain) and IV (ischaemic ulcers or gangrene) or Rutherford category 4 (ischaemic rest pain), 5 (minor tissue loss) or 6 (major tissue loss) * Stenotic (\>50% luminal loss) or occluded infrapopliteal artery, including the tibiofibular trunk, the anterior tibial artery, the posterior tibial artery and the peroneal artery, with a lesion length ≤ 60 mm * Artery to be treated with a diameter more tham or equal to 2mm and less than or equal to 4mm * Patent common iliac, external iliac, superficial femoral and popliteal artery on the ipsilateral side prior to randomisation, possibly after treatment during the same session * At least one patent crural (anterior tibial, posterior tibial or peroneal) artery with expected unobstructed runoff to ankle level after treatment Exclusion Criteria: * Acute limb ischaemia * Subacute limb ischaemia which requires thrombolysis as first treatment modality * Active bleeding or bleeding diathesis * Recent (less than 3 months) hemorrhagic stroke or other any other CNS abnormality with increased risk of haemorrhage, such as intracranial neoplasm, arteriovenous malformation, intracranial aneurysm or aneurysm repair * Gastrointestinal or genitourinary bleeding of clinical significance within the previous 6 weeks before treatment * Aneurysm in common femoral, superficial femoral or popliteal artery on the ipsilateral side * Revascularization involving the same limb within 30 days prior to the index procedure or planned revascularization of the same limb within 30 days of the index procedure * Previous implanted stent at the index site * Life expectancy of less than 6 months or other factors making clinical follow-up difficult * Known allergy to acetylsalicylic acid (aspirin), clopidogrel, heparin or paclitaxel * Known allergy to contrast media * Known heparin induced thrombocytopenia (HIT type 2) * Patient unable or unwilling to tolerate anticoagulant, anti-platelet therapy or contrast media * Creatinine clearance \< 20 ml/min (as derived from Cockcroft-Gault or MDRD formula)unless patient is on hemodialysis * Aneurysm in common femoral, superficial femoral or popliteal artery on the ipsilateral side * Severely calcified lesions with expected resistance to stenting * Poor inflow due to ipsilateral stenoses or occlusions of the iliac or femoropopliteal arteries that cannot be treated during the same session * Significant vessel tortuosity or other parameters prohibiting access to the lesions and/or delivery of the stent * Patients without (expected) distal runoff to the index site * Previous implanted stent at the index site