Actively Recruiting
Thrombolysis With Recombinant Non-immunogenic Staphylokinase vs Surgery in Patients With Acute Limb Ischemia FORAT Trial
Led by Supergene, LLC · Updated on 2025-12-01
170
Participants Needed
8
Research Sites
209 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Thrombolysis With Recombinant Non-immunogenic Staphylokinase vs Surgery in Patients With Acute Limb Ischemia FORAT Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 and older
- Diagnosis of I-II b degree of acute limb ischemia
- Patient consent to use reliable contraceptive methods throughout the study and for 3 weeks after, including women with a negative pregnancy test using approved contraceptives or documented infertility
- Men using barrier contraception or documented infertility
- Signed and dated informed consent to participate in the study
You will not qualify if you...
- 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
- Systolic blood pressure above 180 mm Hg or diastolic blood pressure above 110 mm Hg or need for intravenous drugs to lower blood pressure to these limits
- Pregnancy or lactation
- Known hypersensitivity to Fortelyzin4
- Platelet count less than 100,000/b5L
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Kursk city emergency hospital
Kursk, Kursl Region, Russia, 305035
Actively Recruiting
2
Sergiyev Posad Regional Clinical Hospital
Sergiyev Posad, Moscow Oblast, Russia, 141301
Actively Recruiting
3
Kaliningrad Regional Clinical Hospital
Kaliningrad, Russia, 236016
Actively Recruiting
4
Kazan City Hospital No. 7
Kazan', Russia, 420103
Actively Recruiting
5
S.S. Yudin City clinical hospital
Moscow, Russia, 115446
Actively Recruiting
6
S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center
Moscow, Russia, 125284
Actively Recruiting
7
Ufa Emergency City Hospital
Ufa, Russia, 450092
Actively Recruiting
8
Volgograd City Clinical Hospital of Emergency #25
Volgograd, Russia, 400138
Actively Recruiting
Research Team
S
Sergey S. Markin, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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