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Thrombolysis With Recombinant Non-immunogenic Staphylokinase vs Surgery in Patients With Acute Limb Ischemia FORAT Trial
Sponsor: Supergene, LLC
Summary
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.
Official title: Multicenter, Open-label, Randomized Clinical Trial of Efficacy and Safety of the Thrombolysis With Recombinant Non-immunogenic Staphylokinase (Fortelyzin®) in Patients With ALI vs Surgery
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
170
Start Date
2022-12-26
Completion Date
2026-12-31
Last Updated
2025-12-01
Healthy Volunteers
No
Conditions
Interventions
Recombinant non-immunogenic staphylokinase (Fortelyzin®)
lyophilisate for preparation a solution
surgical methods of treatment
Endovascular intervention, open surgery and/or bypass surgery in accordance with the current National Guidelines
Locations (8)
Kursk city emergency hospital
Kursk, Kursl Region, Russia
Sergiyev Posad Regional Clinical Hospital
Sergiyev Posad, Moscow Oblast, Russia
Kaliningrad Regional Clinical Hospital
Kaliningrad, Russia
Kazan City Hospital No. 7
Kazan', Russia
S.S. Yudin City clinical hospital
Moscow, Russia
S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center
Moscow, Russia
Ufa Emergency City Hospital
Ufa, Russia
Volgograd City Clinical Hospital of Emergency #25
Volgograd, Russia