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 thestudy entry and must utilize reliable birth control for the duration of herparticipation 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 thetibiofibular trunk, the anterior tibial artery, the posterior tibial artery and theperoneal artery, with a lesion length ≤ 60 mm

• Artery to be treated with a diameter more tham or equal to 2mm and less than or equalto 4mm

• Patent common iliac, external iliac, superficial femoral and popliteal artery on theipsilateral side prior to randomisation, possibly after treatment during the samesession

• At least one patent crural (anterior tibial, posterior tibial or peroneal) artery withexpected 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 withincreased risk of haemorrhage, such as intracranial neoplasm, arteriovenousmalformation, intracranial aneurysm or aneurysm repair

• Gastrointestinal or genitourinary bleeding of clinical significance within theprevious 6 weeks before treatment

• Aneurysm in common femoral, superficial femoral or popliteal artery on the ipsilateralside

• Revascularization involving the same limb within 30 days prior to the index procedureor 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-updifficult

• 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 orcontrast media

• Creatinine clearance < 20 ml/min (as derived from Cockcroft-Gault or MDRDformula)unless patient is on hemodialysis

• Aneurysm in common femoral, superficial femoral or popliteal artery on the ipsilateralside

• Severely calcified lesions with expected resistance to stenting

• Poor inflow due to ipsilateral stenoses or occlusions of the iliac or femoropoplitealarteries that cannot be treated during the same session

• Significant vessel tortuosity or other parameters prohibiting access to the lesionsand/or delivery of the stent

• Patients without (expected) distal runoff to the index site

• Previous implanted stent at the index site