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

NCT05933720 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-07-06

No results posted yet for this study

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

Interventions

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.

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

OTHER

Routine conservative treatment

The patients will undergo routine conservative treatment as per clinical guidelines (acetylsalicylic acid 100mg daily, atorvastatin 20mg daily)

Sponsors & Collaborators

  • Ryazan State Medical University

    lead OTHER

Principal Investigators

  • Igor Suchkov · Ryazan State Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2026-06-01
Completion
2026-09-01

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05933720 on ClinicalTrials.gov