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OpenTrials
Completed

NCT Number: NCT04391374

Hemostatic Endothelial Dysfunction in Patients With Peripheral Artery Disease

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

an arterial reconstructive procedure

Procedure

Primary outcomes

  1. thrombosis

    Time frame: 1 year

    incidence of thrombotic complications in the target arterial segment

  2. restenosis

    Time frame: 1 year

    incidence of restenosis in the target arterial segment

  3. progression of atherosclerosis

    Time frame: 1 year

    detection of newly formed or progressing peripheral atherosclerotic lesions

Secondary outcomes

  1. limb salvage rate

    Time frame: 1 year

    limb salvage rate in the target extremity

  2. acute myocardial infarction

    Time frame: 1 year

    incidence of acute myocardial infarction

  3. mortality rate

    Time frame: 1 year

    overall mortality rate

Sponsors and collaborators

Lead sponsor

Ryazan State Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
May 18, 2020
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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