CRAIL - Controlled Reperfusion of the Acutely Ischemic Limb

Prospektive, Randomisierte Multicenter-Studie Zur Optimierung Der Therapie Der Akuten Ischämie Der Unteren Extremitäten Durch Die Kontrollierte Extremitätenreperfusion (Prospective, Randomized Multicenter - Study for Optimization of Therapy of the Acute Ischemic Limb by Controlled Reperfusion)

The purpose of this study is to prove the findings of a preliminary study which strongly suggest the hypothesis that the result of conventional embolectomy for acute, severe lower-limb ischemia can be improved by controlled reperfusion.

Inclusion Criteria:

• Patients aged 18 years or older
• Patients with arterial occlusion of one or both lower limbs with acute decompensated ischemia (Rutherford IIA to III)
• Informed consent of the patient

Exclusion Criteria:

• Previous attempt of recanalisation (e.g. lysis therapy)
• Known A. poplitea aneurysm of the affected extremity
• Severe heart failure NYHA IV
• Known atrial thrombus
• Terminal renal insufficiency (creatinine >10mg/dl or current dialysis therapy, previous transplantation of kidney)
• Hypersensitivity to allopurinol
• Hypersensitivity to one component part of the reperfusion solution
• Participation in a clinical trial during the study or 30 days before
• Pregnancy or lactation
• Patient incapable of contracting or not able to understand the character, meaning and consequences of the clinical trial
• Abuse to drugs or alcohol