Hemostatic Endothelial Dysfunction in Patients With Peripheral Artery Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

167 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2023-03-23

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.

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Conservative treatment

Subjects with atherosclerotic peripheral artery disease (PAD) who undergo standard of care conservative treatment according to the current PAD guidelines.

No interventions assigned to this group

Peripheral artery bypass grafting

Subjects with atherosclerotic peripheral artery disease who undergo an open bypass grafting with synthetic prosthesis in aorto-iliac or femoro-popliteal position

an arterial reconstructive procedure

Intervention Type PROCEDURE

Peripheral artery balloon angioplasty and stenting

Subjects with atherosclerotic peripheral artery disease who undergo endovascular balloon angioplasty and stenting with bare-metal stents in aorto-iliac or femoro-popliteal position

an arterial reconstructive procedure

Intervention Type PROCEDURE

Interventions

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an arterial reconstructive procedure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Males or females older than 40 years of age;
2. Presence of peripheral arterial disease of atherosclerotic origin.

Exclusion Criteria

1. Males or females younger than 40 years of age;
2. Chronic lower limb ischemia of other ethiology (Buerger's disease, aortoarteritis etc.);
3. Active cancer or remission period less than 5 years;
4. Decompensated diabetes mellitus;
5. Pregnancy or breast-feeding for females.

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No