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RECRUITING
NCT05372718
PHASE3

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

Sponsor: Supergene, LLC

View on ClinicalTrials.gov

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

Interventions

DRUG

Recombinant non-immunogenic staphylokinase (Fortelyzin®)

lyophilisate for preparation a solution

PROCEDURE

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