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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who undergo routine conservative treatment | Active Comparator | The patients who undergo routine conservative treatment for peripheral atherosclerotic occlusive disease as per clinical guidelines |
|
| 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 / m, adults 1 vial (5 mg) 1 time / day 2 times a week. The course of treatment is 10 injections. |
|
| Patients who undergo femoral-popliteal bypass with a synthetic graft above the knee | Active Comparator | 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 |
|
| Patients who undergo femoral-popliteal bypass grafting and treatment with polypeptides | Experimental | 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 / m, adults 1 vial (5 mg) 1 time / day 2 times a week. The course of treatment is 10 injections. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polypeptides | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Lower artery or bypass graft thrombosis | The rate of the Lower artery or bypass graft thrombosis | 1 year |
| disease progression | The rate of the disease progression | 1 year |
| restenosis | Restenosis rate | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| limb loss | Limb loss rate | 1 year |
| changes in pain-free walking distance | Changes in the parameter of pain-free walking distance (in meters) |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Igor Aleksadrovich Suchkov | Contact | 8-903-836-24-17 | suchkov_med@mail.ru |
| Name | Affiliation | Role |
|---|---|---|
| Igor Suchkov | Ryazan State Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RyazanSMU | Recruiting | Ryazan | Russia |
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An open, prospective study is aimed at enrolling 120 patients with lower extremity atherosclerotic arterial occlusive disease. Patients are planned to undergo conservative therapy according to indications, including the use of a drug based on vascular polypeptides Slavinorm®, as well as a combination of conservative therapy, including a drug based on vascular polypeptides Slavinorm®, with surgical methods of treatment (femoral-popliteal bypass grafting with a synthetic graft above the knee). Subjects of similar age, gender, and ethnicity should be divided into four groups, respectively.
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|
| 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) |
|
| 1 year |
| changes in ankle-brachial index | Changes in the parameter of ankle-brachial index measured at rest | 1 year |
| ID | Term |
|---|---|
| C564658 | Peripheral Arterial Occlusive Disease 1 |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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| ID | Term |
|---|---|
| D010455 | Peptides |
| ID | Term |
|---|---|
| D000602 | Amino Acids, Peptides, and Proteins |
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