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

NCT05933720 | Recruiting DMC

• 1 other identifier: 10
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peripheral Arterial Occlusive Disease

Keywords

Peripheral Arterial Disease; bypass grafting; polypeptides

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• limb loss

  1 year

• changes in pain-free walking distance

  1 year

• changes in ankle-brachial index

  1 year

Study Arms (4)

Patients who undergo routine conservative treatment

ACTIVE COMPARATOR

The patients who undergo routine conservative treatment for peripheral atherosclerotic occlusive disease as per clinical guidelines

Other: Routine conservative treatment

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.

Drug: Polypeptides

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

Device: Femoral-popliteal bypass grafting with a synthetic graft above the knee; Other: Routine conservative treatment

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.

Drug: Polypeptides; Device: Femoral-popliteal bypass grafting with a synthetic graft above the knee

Interventions

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.

Also known as: vascular polypeptides Slavinorm®, a derivative from cattle vessels

Patients who undergo femoral-popliteal bypass grafting and treatment with polypeptides; Patients who undergo treatment with polypeptides

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

Patients who undergo femoral-popliteal bypass grafting and treatment with polypeptides; Patients who undergo femoral-popliteal bypass 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)

Patients who undergo femoral-popliteal bypass with a synthetic graft above the knee; Patients who undergo routine conservative treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ryazan State Medical University: lead

Study Sites (1)

RyazanSMU

Ryazan, Russia

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1; Peripheral Arterial Disease

Interventions

Peptides

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Igor Suchkov

  Ryazan State Medical University

  STUDY CHAIR

Central Study Contacts

Igor Aleksadrovich Suchkov

CONTACT

8-903-836-24-17; suchkov_med@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident cardiovascular surgeon in the Department of Cardiovascular, Endovascular Surgery and Diagnostic Radiology

Model Details: 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.

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 6, 2023
• Study Start: April 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 6, 2023

Record last verified: 2023-06

Locations

RU (1)