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

NCT05372718 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2025-12-01

No results posted yet for this study

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.

Conditions

  • Acute Limb Ischemia

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

Sponsors & Collaborators

  • Supergene, LLC

    lead INDUSTRY

Principal Investigators

  • Igor I. Zatevakhin, MD, PhD · N.I. Pirogov Russian Medical University, President of the Russian Society of Surgeons

  • Sergey S. Markin, MD, PhD · Supergene, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-26
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05372718 on ClinicalTrials.gov