Thrombolysis With Recombinant Non-immunogenic Staphylokinase vs Surgery in Patients With Acute Limb Ischemia FORAT Trial
Recruiting
Phase 3
Interventional Study
Acute Limb Ischemia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 170 (estimated)
- Sponsor
- Supergene, LLC · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Men and women aged 18 and older;
* Diagnosis of I-II b degree of ALI;
* Patient consent to use reliable contraceptive methods throughout the study and for 3 weeks after:
* women who have a negative pregnancy test and use the following contraceptives: intrauterine devices, o…
Contacts