Efficacy and Safety of the Regulatory Polypeptides in Patients With Peripheral Atherosclerosis.

The study will include 120 patients of similar age, gender, and ethnicity, they will be divided into four groups: Group I: 30 patients with lower extremity atherosclerotic arterial occlusive disease, stage IIA-IIB of the disease according to the Fontaine-Pokrovsky classification, receiving conservative therapy; Group II: 30 patients with lower extremity atherosclerotic arterial occlusive disease, stage IIA-IIB of the disease according to the Fontaine-Pokrovsky classification, receiving conservative therapy, including the drug based on vascular polypeptides Slavinorm®; Group III: 30 patients with lower extremity atherosclerotic arterial occlusive disease, stageIII-IV of the disease according to the Fontaine-Pokrovsky classification, receiving conservative therapy in combination with surgical methods of treatment (femoral-popliteal bypass grafting with a synthetic graft above the knee); Group IV: 30 patients with lower extremity atherosclerotic arterial occlusive disease, stage III-IV of the disease according to the Fontaine-Pokrovsky classification, receiving conservative therapy, including the drug based on vascular polypeptides Slavinorm®, in combination with surgical methods of treatment (femoral-popliteal bypass grafting with a synthetic graft above the knee).

• Polypeptides (Drug), also known as vascular polypeptides Slavinorm®, a derivative from cattle vessels: The patients will undergo treatment with a drug based on vascular polypeptides Slavinorm®, a derivative from cattle vessels, registered in Russia for the treatment of patients with peripheral atherosclerotic occlusive disease.
• Femoral-popliteal bypass grafting with a synthetic graft above the knee (Device): The patients with undergo an arterial revascularization - Femoral-popliteal bypass grafting with a synthetic graft above the knee
• Routine conservative treatment (Other): The patients will undergo routine conservative treatment as per clinical guidelines (acetylsalicylic acid 100mg daily, atorvastatin 20mg daily)

Primary outcomes

• Lower artery or bypass graft thrombosis [1 year]: The rate of the Lower artery or bypass graft thrombosis
• disease progression [1 year]: The rate of the disease progression
• restenosis [1 year]: Restenosis rate

Secondary outcomes

• limb loss [1 year]: Limb loss rate
• changes in pain-free walking distance [1 year]: Changes in the parameter of pain-free walking distance (in meters)
• changes in ankle-brachial index [1 year]: Changes in the parameter of ankle-brachial index measured at rest

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria:

men or women over 18 years of age with lower extremity atherosclerotic arterial occlusive disease, confirmed with instrumental work-up methods (ultrasonography or angiography).

Exclusion Criteria:

men or women under 18 years of age; history of anaphylaxis; hypersensitivity to any of the components that make up the drug Slavinorm®, and proteins of animal origin; absolute and relative contraindications to the treadmill test; failure to walk at a minimum speed of 3.2 km/h (2 mph) at a minimum treadmill angle for at least 2 minutes during the stress test during the screening phase; depression of the ST segment more than 1 mm in one or more standard leads on the electrocardiogram; peripheral artery disease not associated with atherosclerosis; patients who underwent reconstructive surgery or invasive interventions on the arteries of the lower extremities in history without a clinic of intermittent claudication; angina pectoris III-IV functional class (FC) according to the CCS classification; body mass index >35 kg/m2; acute or chronic renal (creatinine clearance less than 30 ml / min) and / or liver failure \[aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 3 times the upper limit of normal\]; chronic heart failure III-IV FC according to NYHA; acute coronary syndrome within 6 months. before the start of the screening period; any clinically significant condition or comorbidity that, in the opinion of the Investigator, would preclude the patient from participating in the study.

• Igor Suchkov, Study chair, Ryazan State Medical University