Sergiyev Posad

Researchers are investigating the effectiveness and safety of using recombinant non-immunogenic staphylokinase (Fortelyzin4) administered directly into the artery at the site of the clot in patients with acute limb ischemia (ALI) compared to traditional surgery. This phase 3 clinical trial focuses on patients with ALI of degrees I to II b, aiming to find better treatment options since intravenous thrombolysis is ineffective for this condition. Previous studies with Fortelyzin4 in heart attack and stroke patients showed promising results with fewer bleeding complications and no immune reactions. The study compares two treatment approaches: intra-arterial thrombolysis with Fortelyzin4, a fibrin-selective clot-busting drug given as a lyophilisate solution, and surgical methods including endovascular intervention, open surgery, or bypass surgery following national guidelines. Patients will be randomly assigned to either receive Fortelyzin4 directly at the clot or undergo one of the surgical procedures. The trial is open-label and conducted at multiple centers. Participants will be monitored to see if they avoid amputations within 30 days after treatment. Researchers will assess safety and effectiveness through clinical evaluations and track adverse events. Informed consent and contraceptive use during and after the study are required for participants. The study includes follow-up to measure outcomes and ensure participant safety over the trial period.