Hemostatic Endothelial Dysfunction in Patients With Peripheral Artery Disease

Completed

• Conditions: Restenosis of Peripheral Vascular Stent; Peripheral Artery Disease; Restenosis, Vascular Graft; Endothelial Dysfunction
• Interventions: Procedure: an arterial reconstructive procedure

• Registration Number: NCT04391374
• Lead Sponsor: Ryazan State Medical University

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.

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-05-13
• Study First Posted: 2020-05-18
• Primary Completion: 2023-02-23
• Study Completion: 2023-03-23
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-01
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Peripheral artery bypass grafting	an arterial reconstructive procedure	Subjects with atherosclerotic peripheral artery disease who undergo an open bypass grafting with synthetic prosthesis in aorto-iliac or femoro-popliteal position
Peripheral artery balloon angioplasty and stenting	an arterial reconstructive procedure	Subjects with atherosclerotic peripheral artery disease who undergo endovascular balloon angioplasty and stenting with bare-metal stents in aorto-iliac or femoro-popliteal position

Primary Outcome Measures

Name	Time	Method
progression of atherosclerosis	1 year	detection of newly formed or progressing peripheral atherosclerotic lesions
restenosis	1 year	incidence of restenosis in the target arterial segment
thrombosis	1 year	incidence of thrombotic complications in the target arterial segment

Secondary Outcome Measures

Name	Time	Method
limb salvage rate	1 year	limb salvage rate in the target extremity
acute myocardial infarction	1 year	incidence of acute myocardial infarction
mortality rate	1 year	overall mortality rate