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RECRUITING
NCT05933720
NA

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

Sponsor: Ryazan State Medical University

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2023-04-01

Completion Date

2026-09-01

Last Updated

2023-07-06

Healthy Volunteers

No

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)

Locations (1)

RyazanSMU

Ryazan, Russia