Objective: to evaluate the efficacy and safety of intra-arterial intrathrombus administration of the recombinant non-immunogenic staphylokinase (Fortelyzin®) in patients with acute limb ischemia (ALI) vs surgery.
Men and women aged 18 and older;
Diagnosis of I-II b degree of ALI;
women who have a negative pregnancy test and use the following contraceptives: intrauterine devices, oral contraceptives, contraceptive patch, prolonged injectable contraceptives, double barrier method of contraception. Women who are not fertile can also take part in the study (documented conditions: hysterectomy, tubal ligation, infertility, menopause for more than 1 year);
men using barrier contraception. The study may also involve men who are not fertile (documented conditions: vasectomy, infertility);
Extensive bleeding at present;
Intracranial (including subarachnoid) hemorrhage at present;
Recent gastrointestinal bleeding (within 10 days);
Major surgery or major trauma within the previous 3 months, recent traumatic brain injury;
Supergene, LLC
Lead sponsor