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

Ryazan State Medical University0 sites167 target enrollmentJanuary 2017

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

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Artery Disease
Sponsor: Ryazan State Medical University
Enrollment: 167
Primary Endpoint: progression of atherosclerosis
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

January 2017

End Date

March 23, 2023

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Ryazan State Medical University

Responsible Party

Sponsor

Eligibility Criteria

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.