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

ConditionPeripheral Arterial Occlusive Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRyazan State Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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 intervention

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

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: Patients who undergo routine conservative treatmentActive comparator 1 intervention
Group B: Patients who undergo treatment with polypeptidesExperimental treatment 1 intervention
Group C: Patients who undergo femoral-popliteal bypass with a synthetic graft above the kneeActive comparator 2 interventions
Group D: Patients who undergo femoral-popliteal bypass grafting and treatment with polypeptidesExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Lower artery or bypass graft thrombosis

The rate of the Lower artery or bypass graft thrombosis

Time frame
1 year
2

disease progression

The rate of the disease progression

Time frame
1 year
3

restenosis

Restenosis rate

Time frame
1 year

Secondary outcomes

1

limb loss

Limb loss rate

Time frame
1 year
2

changes in pain-free walking distance

Changes in the parameter of pain-free walking distance (in meters)

Time frame
1 year
3

changes in ankle-brachial index

Changes in the parameter of ankle-brachial index measured at rest

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ryazan State Medical University

Lead sponsor

Source ClinicalTrials.gov
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