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Hemostatic Endothelial Dysfunction in Patients With Peripheral Artery Disease

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04391374
Enrollment
167
Registered
2020-05-18
Start date
2017-01-31
Completion date
2023-03-23
Last updated
2023-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

hemostasis, endothelial dysfunction, restenosis, thrombosis

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.

Interventions

PROCEDUREan arterial reconstructive procedure

Sponsors

Ryazan State Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
thrombosis1 yearincidence of thrombotic complications in the target arterial segment
restenosis1 yearincidence of restenosis in the target arterial segment
progression of atherosclerosis1 yeardetection of newly formed or progressing peripheral atherosclerotic lesions

Secondary

MeasureTime frameDescription
limb salvage rate1 yearlimb salvage rate in the target extremity
acute myocardial infarction1 yearincidence of acute myocardial infarction
mortality rate1 yearoverall mortality rate

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026