Hemostatic Endothelial Dysfunction in Patients With Peripheral Artery Disease

Study Overview
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Brief Summary
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The study is aimed at evaluating the role of the activity of the key hemostatic parameters of endothelial dysfunction (nitric oxide II (NO) metabolites, plasmin activator inhibitor-1 (PAI-1), von Willebrand factor (vWF), coagulation factor VIII (FVIII), soluble endothelial protein C receptors (sEPCR)) in the development of disease progression, thrombotic complications and restenosis in subjects with atherosclerotic peripheral artery disease.

Detailed Description
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The study will involve patients with atherosclerotic peripheral artery disease (Rutherford category 3-5). The subjects are to be divided into three groups: Group A: patients who undergo bypass surgery with a synthetic graft on aorto-iliac or femoro-popliteal segment; Group B: patients who undergo endovascular balloon angioplasty and stenting on aorto-iliac or femoro-popliteal segment; Group C: patients who undergo standard of care conservative treatment. Decisions on revascularization or conservative treatment alone is to be made by a team of vascular specialists in accordance with the severity of the disease, previous treatment, anatomy, possible need for repeat procedures in the future, and patient's preferences.

Official Title
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The Role of Hemostatic Markers of Endothelial Dysfunction in the Development of Disease Progression, Thrombotic Complications and Restenosis in Patients With Atherosclerotic Peripheral Artery Disease

Conditions
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Peripheral Artery Disease, Restenosis of Peripheral Vascular Stent, Restenosis, Vascular Graft, Endothelial Dysfunction

Intervention / Treatment
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* Procedure: an arterial reconstructive procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females older than 40 years of age; Presence of peripheral arterial disease of atherosclerotic origin. Exclusion Criteria: Males or females younger than 40 years of age; Chronic lower limb ischemia of other ethiology (Buerger's disease, aortoarteritis etc.); Active cancer or remission period less than 5 years; Decompensated diabetes mellitus; Pregnancy or breast-feeding for females.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Conservative treatment<br>Subjects with atherosclerotic peripheral artery disease (PAD) who undergo standard of care conservative treatment according to the current PAD guidelines. | |
| Peripheral artery bypass grafting<br>Subjects with atherosclerotic peripheral artery disease who undergo an open bypass grafting with synthetic prosthesis in aorto-iliac or femoro-popliteal position | Procedure: an arterial reconstructive procedure<br> <br> |
| Peripheral artery balloon angioplasty and stenting<br>Subjects with atherosclerotic peripheral artery disease who undergo endovascular balloon angioplasty and stenting with bare-metal stents in aorto-iliac or femoro-popliteal position | Procedure: an arterial reconstructive procedure<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thrombosis | incidence of thrombotic complications in the target arterial segment | 1 year | 
| restenosis | incidence of restenosis in the target arterial segment | 1 year | 
| progression of atherosclerosis | detection of newly formed or progressing peripheral atherosclerotic lesions | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| limb salvage rate | limb salvage rate in the target extremity | 1 year | 
| acute myocardial infarction | incidence of acute myocardial infarction | 1 year | 
| mortality rate | overall mortality rate | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemostasis, endothelial dysfunction, restenosis, thrombosis