Phase
Condition
Peripheral Arterial Occlusive Disease
Treatment
Femoral-popliteal bypass grafting with a synthetic graft above the knee
Polypeptides
Routine conservative treatment
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: men or women over 18 years of age with lower extremity atherosclerotic arterial occlusivedisease, confirmed with instrumental work-up methods (ultrasonography or angiography).
Exclusion
Exclusion Criteria: men or women under 18 years of age; history of anaphylaxis; hypersensitivity to any of thecomponents that make up the drug Slavinorm®, and proteins of animal origin; absolute andrelative contraindications to the treadmill test; failure to walk at a minimum speed of 3.2km/h (2 mph) at a minimum treadmill angle for at least 2 minutes during the stress testduring the screening phase; depression of the ST segment more than 1 mm in one or morestandard leads on the electrocardiogram; peripheral artery disease not associated withatherosclerosis; patients who underwent reconstructive surgery or invasive interventions onthe arteries of the lower extremities in history without a clinic of intermittentclaudication; angina pectoris III-IV functional class (FC) according to the CCSclassification; body mass index >35 kg/m2; acute or chronic renal (creatinine clearanceless than 30 ml / min) and / or liver failure [aspartate aminotransferase (AST), alanineaminotransferase (ALT) > 3 times the upper limit of normal]; chronic heart failure III-IVFC according to NYHA; acute coronary syndrome within 6 months. before the start of thescreening period; any clinically significant condition or comorbidity that, in the opinionof the Investigator, would preclude the patient from participating in the study.
Study Design
Study Description
Connect with a study center
RyazanSMU
Ryazan,
Russian FederationActive - Recruiting
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