RecruitingPhase 3NCT05372718

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

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

Sponsor

Supergene, LLC

Enrollment

170 participants

Start Date

Dec 26, 2022

Study Type

INTERVENTIONAL

Conditions

Acute Limb Ischemia

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Recombinant non-immunogenic staphylokinase (Fortelyzin®) and a procedure called surgical methods of treatment for people with acute limb ischemia. The study is currently recruiting participants at 8 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRecombinant non-immunogenic staphylokinase (Fortelyzin®)

lyophilisate for preparation a solution

PROCEDUREsurgical 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

View Full Details on ClinicalTrials.gov

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NCT05372718

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