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;
Parallel
Recombinant non-immunogenic staphylokinase (Fortelyzin®)
Druglyophilisate for preparation a solution
surgical methods of treatment
Procedure/SurgeryEndovascular intervention, open surgery and/or bypass surgery in accordance with the current National Guidelines
Number of patients without amputations
Outcome Measure is evaluated in terms of the number of patients without amputations
Safety endpoint - Death from all causes
The safety is evaluated in terms of the number of deaths from all causes
Safety endpoint - hemorrhagic stroke
The safety is evaluated in terms of the number of hemorrhagic stroke
Safety endpoint - BARC type 3 and 5 bleeding
The safety is evaluated in terms of the number of BARC type 3 and 5 bleeding
Safety endpoint - Number and severity of serious adverse events (SAEs) and AEs in organs and systems
The safety is evaluated in terms of the number and severity of SAEs and AEs in organs and systems
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