Study Comparing Thrombolysis Using Recombinant Non-immunogenic Staphylokinase Fortelyzin4 Versus Surgery in Adults With Acute Limb Ischemia

What this Trial Is About

This research aims to evaluate the effectiveness and safety of intra-arterial intrathrombus administration of recombinant non-immunogenic staphylokinase Fortelyzin4 compared to surgery in patients experiencing acute limb ischemia ALI. ALI is a serious condition with high mortality, and this study focuses on a thrombolytic treatment that targets clot breakdown directly within affected arteries. The trial builds on previous studies showing promising results with this staphylokinase in heart attacks and strokes, assessing its role specifically in ALI. Participants will be randomly assigned to receive either Fortelyzin4 delivered directly into the blood clot via a catheter or surgical treatment including endovascular intervention, open surgery, or bypass surgery based on current national guidelines. The Fortelyzin4 treatment involves an initial bolus injection followed by a continuous infusion over ten hours through a perforated multihole catheter. Surgery will be conducted according to standard practice. This is an open-label, multicenter Phase 3 trial. During the study, participants will be monitored for 30 days after randomization to assess outcomes, focusing primarily on the number of patients who avoid amputation. Assessments will include safety monitoring for bleeding and other adverse events. Informed consent and contraception adherence are required, and ongoing patient evaluations will help researchers understand the comparative benefits and risks of these treatment approaches for ALI.

Thrombolysis With Recombinant Non-immunogenic Staphylokinase vs Surgery in Patients With Acute Limb Ischemia FORAT Trial