[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100510998":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":47,"centralContacts":51,"locations":57,"responsibleParty":73,"collaborators":42,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":42,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":42,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":60,"whyStopped":42,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Ryazan State Medical University","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients who undergo routine conservative treatment","ACTIVE_COMPARATOR","The patients who undergo routine conservative treatment for peripheral atherosclerotic occlusive disease as per clinical guidelines",[13],"Other: Routine conservative treatment",{"label":15,"type":16,"description":17,"interventionNames":18},"Patients who undergo treatment with polypeptides","EXPERIMENTAL","The patients who undergo treatment with a complex of polypeptides isolated from the vessels of cattle is administered in \u002F m, adults 1 vial (5 mg) 1 time \u002F day 2 times a week. The course of treatment is 10 injections.",[19],"Drug: Polypeptides",{"label":21,"type":10,"description":22,"interventionNames":23},"Patients who undergo femoral-popliteal bypass with a synthetic graft above the knee","Patients who undergo the surgical method of treatment i.e. femoral-popliteal bypass grafting with a synthetic graft above the knee and routine conservative treatment as per clinical guidelines",[24,13],"Device: Femoral-popliteal bypass grafting with a synthetic graft above the knee",{"label":26,"type":16,"description":27,"interventionNames":28},"Patients who undergo femoral-popliteal bypass grafting and treatment with polypeptides","Patients who undergo the surgical method of treatment i.e. femoral-popliteal bypass grafting with a synthetic graft above the knee with following treatment with a complex of polypeptides isolated from the vessels of cattle is administered in \u002F m, adults 1 vial (5 mg) 1 time \u002F day 2 times a week. The course of treatment is 10 injections.",[19,24],[30,37,43],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Polypeptides","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.",[26,15],[36],"vascular polypeptides Slavinorm®, a derivative from cattle vessels",{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"DEVICE","Femoral-popliteal bypass grafting with a synthetic graft above the knee","The patients with undergo an arterial revascularization - Femoral-popliteal bypass grafting with a synthetic graft above the knee",[26,21],null,{"type":6,"name":44,"description":45,"armGroupLabels":46,"otherNames":42},"Routine conservative treatment","The patients will undergo routine conservative treatment as per clinical guidelines (acetylsalicylic acid 100mg daily, atorvastatin 20mg daily)",[21,9],[48],{"name":49,"affiliation":5,"role":50},"Igor Suchkov","STUDY_CHAIR",[52],{"name":53,"role":54,"phone":55,"phoneExt":42,"email":56},"Igor Aleksadrovich Suchkov","CONTACT","8-903-836-24-17","suchkov_med@mail.ru",[58],{"facility":59,"status":60,"city":61,"state":42,"zip":42,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"RyazanSMU","RECRUITING","Ryazan","Russia","RU",{"type":65,"coordinates":66},"Point",[67,68],39.70415,54.62696,{"lat":68,"lon":67},[71],{"name":49,"role":54,"phone":72,"phoneExt":42,"email":56},"+79038362417",{"type":74,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"PRINCIPAL_INVESTIGATOR","Lyasheva Anastasia Vladimirovna","Resident cardiovascular surgeon in the Department of Cardiovascular, Endovascular Surgery and Diagnostic Radiology","100510998","efficacy-and-safety-of-the-regulatory-polypeptides-in-patients-with-peripheral-atherosclerosis-100510998",false,"NCT05933720","Efficacy and Safety of the Regulatory Polypeptides in Patients With Peripheral Atherosclerosis.","Evaluation of the Efficacy and Safety of the Drug Based on Vascular Regulatory Polypeptides for the Treatment of Patients With Lower Extremity Atherosclerotic Arterial Occlusive Disease.","Inclusion Criteria:\n\nmen or women over 18 years of age with lower extremity atherosclerotic arterial occlusive disease, confirmed with instrumental work-up methods (ultrasonography or angiography).\n\nExclusion Criteria:\n\nmen 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\u002Fh (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\u002Fm2; acute or chronic renal (creatinine clearance less than 30 ml \u002F min) and \u002F 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.","ALL","18 Years","80 Years",{"count":88,"type":89},120,"ESTIMATED","INTERVENTIONAL",[92],"NA","The study is aimed at assessing the role of the activity of markers of endothelial dysfunction (cytotoxic malonic aldehyde (MDA), angiotensin II, endothelial nitric oxide synthase (NO), endothelin-1, prostacyclin) in the systemic circulation in patients with lower extremity atherosclerotic arterial occlusive disease undergoing open reconstructive interventions.",[95],"Peripheral Arterial Occlusive Disease",[97,98,99],"Peripheral Arterial Disease","bypass grafting","polypeptides","2023-06-27",{"date":102,"type":103},"2023-07-06","ACTUAL",{"date":105,"type":103},"2023-04-01",{"date":107,"type":89},"2026-09-01",{"name":5,"class":6},1]